EXCEL 60-6050-098Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405012009), received between Dec 3, 2018 and Dec 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 3, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR IN (B)(6) REPORTED A "TEAR" ON THE STERILE POUCH OF THE 60-6050-098 DEVICE. THIS WOULD BE AN OBVIOUS DEFECT TO THE USER AND WAS THEREFORE NOT DEEMED A REPORTED DEVICE FAILURE. HOWEVER, THE COMPLAINT DEVICE WAS RETURNED TO CONMED FOR EVALUATION AND A STERILE BREACH WAS FOUND WHICH WAS LIKELY CAUSED BY THE DEVICE. NO PATIENT INVOLVEMENT AS THIS DEFECT WAS FOUND DURING INCOMING INSPECTION. THIS INCIDENT WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 8125518 ↗