NA 215459Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705005123), received between Jul 2, 2020 and Jul 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER SCOPE THE DELAMINATION OF TWO OF THE STERILIZATION CASE LIDS WAS COMING OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE(S) IS/ARE AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REPORTED BY THE AFFILIATE STATED THE LOT NUMBER IS UNKNOWN BECAUSE IT IS NOT ON THE OVER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10225026 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER SCOPE THE DELAMINATION OF TWO OF THE STERILIZATION CASE LIDS WAS COMING OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE(S) IS/ARE AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REPORTED BY THE AFFILIATE STATED THE LOT NUMBER IS UNKNOWN BECAUSE IT IS NOT ON THE OVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10225020 ↗