Z-0696-2018Class II

A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to...

Name: Z-0696-2018 A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to...
Creator: Olympus Corporation of the Americas
Published: 2017-08-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2017-08-18 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2017-08-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0696-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-18
Posted: 2018-02-23
Terminated: 2020-07-07
Recalling firm: OLYMPUS Corporation of the Americas
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: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
Product code: GCP Endoscope, Ac-Powered And Accessories
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 8741
Distribution: US Nationwide Distribution
Product codes and lots: Model Numbers and Associated Lot Numbers: A20975A -- 13-ZW to 172W A20976A -- 146W to 172W A20977A -- 146W to 174W

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0696-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0696-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code GCP

K790071Class IIEndoscope and AccessoriesOlympus Corp. / cleared 1979-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)