NA 215411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705004737), received between Dec 26, 2018 and Jun 7, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA CST THAT PRIOR TO AN ACL RECONSTRUCTION PROCEDURE THE TWO ACL TRAYS CONTAINED A BROWN DISCHARGE THAT WAS DRIED OUT AND ON THE INSIDE OF THE WRAPPING AFTER STERILIZATION. THE SAME TRAYS WERE RAN THROUGH THE WASH AND STERILIZATION EQUIPMENT AGAIN AND THERE WAS STILL A BROWN DISCHARGE ON THE INSIDE WRAPPING. THE SALES REP WAS NOT SURE IF IT WAS RUST OR SOIL COMING FROM THE INSIDE CANNULATION OR THE ENTIRE TRAYS WITH THEIR INSTRUMENTS. THE CASE WAS COMPLETED USING A THIRD ACL TRAY FULL OF INSTRUMENTS. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679318 ↗
• MalfunctionJun 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA CST THAT PRIOR TO AN ACL RECONSTRUCTION PROCEDURE THE TWO ACL TRAYS CONTAINED A BROWN DISCHARGE THAT WAS DRIED OUT AND ON THE INSIDE OF THE WRAPPING AFTER STERILIZATION. THE SAME TRAYS WERE RAN THROUGH THE WASH AND STERILIZATION EQUIPMENT AGAIN AND THERE WAS STILL A BROWN DISCHARGE ON THE INSIDE WRAPPING. THE SALES REP WAS NOT SURE IF IT WAS RUST OR SOIL COMING FROM THE INSIDE CANNULATION OR THE ENTIRE TRAYS WITH THEIR INSTRUMENTS. THE CASE WAS COMPLETED USING A THIRD ACL TRAY FULL OF INSTRUMENTS. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679202 ↗
• MalfunctionDec 26, 2018Residue After Decontamination; Residue After Decontamination

  IT LOOKS LIKE SOME PLASTIC MATERIAL WAS LEFT INSIDE TRAY CONTAINER AND MELTED IN A SMALL POOL AT THE BOTTOM OF THE TRAY WHEN IT WAS AUTOCLAVED. NO PATIENT CONSEQUENCE. THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON 10/11/2018 STATING THERE WAS A REPORTED SURGICAL DELAY OF 32.5 SECONDS. THE CASE WAS COMPLETED BY OPENING ANOTHER LIKE TRAY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8195983 ↗