ACS CDHI12DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072046130), received between Sep 19, 2019 and Sep 19, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 19, 2019Device Contamination with Chemical or Other Material

  QUESTIONABLE STERILITY ASSURANCE ISSUE; WHAT APPEARED TO BE A DEAD BUG WAS FOUND IN THE SELF CONTAINED BASIN/WRAP WITHIN IN THE STERILE SUPPLY PACK. BUG WAS LOST DURING EXAMINATION PROCESS, THEREFORE CAN NOT PROVIDE FOR EXAMINATION. ISSUE IDENTIFIED & RECTIFIED; NO PATIENT EXPOSURE. INTRA-OP STAFF REPORTS THE FOLLOWING. WHILE SETTING UP FOR THE CASE AFTER THE PATIENT WAS ALREADY IN THE OPERATING ROOM, A QUESTIONABLE BUG WAS FOUND IN THE BLUE BASIN IN THE ORTHO MAJOR PACK. THE BLUE BASIN WAS WRAPPED SEPARATELY FROM THE REST OF THE PACK. AFTER THE SCRUB TECH DISCOVERED THE QUESTIONABLE BUG, SHE DID NOT TOUCH ANYTHING ELSE ON THE STERILE FIELD. SHE ALSO HAD NOT REMOVED ANYTHING FROM THE WRAPPED BASIN. SCRUB TECH REMOVED GLOVES AND TRANSFERRED INSTRUMENTS TO A SEPARATE STERILE FIELD. SURGEON NOTIFIED. A NEW PACK WAS OPENED. QUALITY WAS INFORMED AND PACK WAS SAVED.

  Patient problems: No Patient Involvement

  MAUDE report 9086604 ↗