CONMED 00505217300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854006429), 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 THIS 00505217300 BLADE WAS IN THE SEALING 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 DEVICE WAS RETURNED TO CONMED AND R AND D DETERMINED BY WAY OF DYE LEAK TESTING THERE WAS A BREACH IN STERILITY ON (B)(6) 2017. THE REGULATORY RATIONALE WAS UPDATED TO REFLECT THE EVALUATION FINDINGS, DEEMING THIS A REPORTABLE EVENT ON 30-NOV-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 7101461 ↗