CONMED 00505953200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854006177), received between Dec 8, 2017 and Dec 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2017Packaging Problem; Packaging Problem

  THE DISTRIBUTOR REPORTED TEN 00505953200 BLADES' INNER POUCHES WERE PUT IN THE SEAL AREA. THIS WAS FOUND DURING INCOMING INSPECTION, THEREFORE, THERE WAS NO PATIENT CONTACT. THIS COMPLAINT WAS REVIEWED AND A REGULATORY RATIONALE OF "NON-REPORTABLE" WAS DOCUMENTED. THE REPORTED DEVICES WERE RETURNED TO CONMED AND R&D DETERMINED BY WAY OF DYE LEAK TESTING THERE WAS A BREACH IN STERILITY OF 4 DEVICES ON 29-NOV-2017. THE REGULATORY RATIONALE WAS UPDATED TO REFLECT THE EVALUATION FINDINGS, DEEMING THIS A REPORTABLE EVENT ON (B)(6) 2017. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101726 ↗