Olympus Recalls Urologic Endoscopic Working Inserts and Bridges Due to Adhesive Fragments
Olympus is recalling specific urologic endoscopic working inserts and bridges because adhesive fragments may detach and enter patients during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (foreign body in patient requiring retrieval or additional surgery) where injury has not been reported, fitting the 'High' severity criteria.
Plain-English summary
Olympus Corporation of the Americas is recalling 8,741 units of A20975A working inserts and A20976A and A20977A bridges used for endoscopic diagnosis and treatment in urologic applications. The recall covers specific lot numbers for these devices, which were distributed nationwide in the United States.
The recall was initiated after complaints that adhesive fragments detached from inside the working channel of the devices. Reports also noted cracking, chipping, missing pieces, and delamination of the adhesive. In one instance, an adhesive fragment was found inside a patient's urethra during a procedure and was retrieved without causing injury. The manufacturer determined that the adhesive, which was replaced in 2013, has insufficient durability and can be dislodged when instruments are inserted through the working channel.
If adhesive fragments fall into a patient's bladder, urethra, or uterus, they must be retrieved, which can extend the length of the procedure or require additional surgical treatment. Healthcare facilities should stop using the affected devices and contact Olympus for instructions on returning them.
The recalled product
- Product
- A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 8,741
Distribution
Distributed nationwide across the United States.
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