An endoscopy is a routine procedure that uses a scope or camera to take pictures or videos of organs and other internal structures. These procedures are used by healthcare providers to diagnose and treat conditions affecting the GI tract. The three most common types of endoscopic procedures include colonoscopy, upper endoscopy, and laparoscopy. In most cases, endoscopic procedures pose little to no risk to patients.
Dangers of Endoscopic Procedures
Although generally a safe procedure, complications from endoscopic procedures can be severe. If the device malfunctions, or the provider fails to follow proper procedure, patients can suffer from severe bleeding, infection, or tearing of the GI tract, requiring additional surgical intervention. In these circumstances, injuries to patients can be severe and life-altering.
Scope Injuries: A Result of the Product or the Medical Provider?
It’s important to distinguish between injuries caused by a device malfunction and injuries caused by medical negligence or medical malpractice. Negligence is failure to use a level of care that a reasonable person would have exercised under similar circumstances. Medical negligence occurs when a healthcare provider fails to meet their duty to a patient. If a patient suffers harm resulting from medical negligence, there may be an action for medical malpractice. If a medical provider fails to inspect a device before use to make sure it’s in good working condition, or if a medical provider performs the procedure in a manner that’s contrary to the generally accepted methods and the patient is injured, there may be grounds for a medical malpractice claim.
If the device being used by the doctor malfunctions during the procedure and injures the patient, the manufacturer may be liable for damages to the patient under a product liability cause of action. Product liability actions involving endoscopic devices typically arise when a piece of equipment used during a procedure fails to perform as intended and causes patient harm. These claims focus not on the medical provider’s decisions, but on whether the device itself was defectively designed, poorly manufactured, or sold without adequate warnings about known risks.
Depending on the device’s repair history, there may be a claim against the repair facility (if different from the manufacturer) or the outpatient clinic for allowing a defective and improperly maintained device to remain in service and be used in procedures.
Understanding FDA Product Recalls
Endoscopy relies on complex, high-precision instruments, and even a small defect can lead to serious internal injury. As a result, endoscopic products are monitored by the FDA to protect consumers from risks. Generally, recalls are initiated by the manufacturer of a product once they learn the product violates FDA law, and they notify the FDA, although the FDA does have the authority to require a company to issue a recall if it needs to. Recalls come in the form of corrections or removals. A correction addresses problems with a medical device like relabeling, or adjustments or modifications that can be done without taking the device away. A correction doesn’t require removing the product from the market. A removal addresses a more serious problem with a medical device by removing the item from the market so that it cannot be used by medical providers or consumers. Once removed, devices must either be repaired or modified, or otherwise destroyed and replaced.
Recent Scope Recalls
- November 2025 Recall: Olympus issued a recall on Olympus Single Use PolyLoop Ligating Devices due to reports of severe tissue and mucosal injury, severe bleeding, and related complications. A litigation device is a medical tool used to treat bleeding during endoscopic procedures. As of October 1, 2025, Olympus reported 113 serious injuries associated with this issue.
- October 2025 Recall: The FDA reported on Aizu Olympus Co.’s Class 2 device recall on the Olympus Endoscopic Reprocessor OERMini, an accessory used for cleaning endoscopes that could potentially lead to injury.
- August 2025 Recall: Olympus Corporation of the Americas issued a recall on certain Olympus ViziShot 2 Flex Tissue Biopsy Devices due to patient safety issues caused by a potentially deformed a-traumatic tip, a component of the device's needle. Use may lead to serious adverse health consequences including mucosal injury and bleeding, infection, and death. To date, there have been 40 reported injuries and one death related to the issue.
- February 2025 Recall: Olympus Corporation of the Americas issued a recall for Olympus Single Use Guide Sheath Kits due to risk of detachment during endoscopic procedures. Used with an endoscope to collect cell or tissue specimens from organs, the device has been linked to serious adverse health consequences, including bleeding and death. As of February 28th, 2025, 26 serious injuries had been reported in connection with this device.
- December 2024 Recall: Olympus issued a recall for the Olympus MAJ-891 Forceps/Irrigation Plug, an accessory used with a cystoscope (CYF scope) during an endoscopy. Exposure to the contaminated device could result in patient injury including infection, urinary tract infection, sepsis, or death. Olympus has reported 120 injuries and 1 death due to infection following procedures in which the MAJ-891 was used with a CYF scope.
