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Terminated

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

FDA Recall Z-2629-2017 · Posted None

Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeGCP
Date Initiated2017-04-19
Date Terminated2018-10-01
Product Quantity1264 units

Reason for Recall

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

Firm Action

Olympus sent an Urgent Medical Device Removal Notice dated April 26, 2017, to affected customers to inform them of the issue. The notice identified the issue, the actions to be taken by the end user. It advised that customers discontinue use of any affected electrodes if found, contact Olympus Customer Care Center and they will provide instructions on how to return the affected product as well get a free replacement. Customer were instructed fax the completed reply from to 484-896-7128. Customer with questions should call 484-896-5688. For questions regarding this recall call 484-896-5000.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K790071ENDOSCOPE AND ACCESSORIESOlympus Corp. · 1979-04-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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