Device Recall A20975A: Working insert, with ramp, one way; A20976A: Bridge, one way; A20977A; Bridge, two way 의 리콜

Recall

79017

Class 2

Z-0696-2018

2017-08-18

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161176

Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. in one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. the manufacturer, olympus winter & lbe gmbh ("owi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.G., when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. the adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. in 2013, the adhesive used until then was discontinued and had to be replaced. current investigations revealed that the durability of the new adhesive is insufficient.

On August 18, 2017 an URGENT Medical Device Removal and Corrective Action letter was sent to customers regarding the "Cystoscopy Bridges and Working Inserts" instructing customers to review their inventory, quarantine affected product and call customer service at 800-848-9024 to arrange return and replacement.