V. Mueller OS3032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403102769), received between Aug 25, 2023 and Sep 14, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 14, 2023Break; Break

  DURING A CABG PROCEDURE, THE BLACK RUBBER TIP INSERT OF THE WIRE CUTTER CRACKED IN HALF. A PIECE FELL INTO THE PATIENT'S BODY AND WAS RETRIEVED BY THE SURGICAL TEAM. NO ADDITIONAL MEDICAL PROCEDURE WAS REQUIRED FOR VERIFICATION PURPOSES AND THE PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17742955 ↗
• MalfunctionAug 25, 2023Break; Break

  "BLACK INSERT PIECE CRACKED IN HALF DURING PROCEDURE". NO PATIENT IMPACT. 22AUG2023 ADDITIONAL INFORMATION: WHAT IS THE LOT NUMBER FOR THE DEFECTIVE CUTTER? K22XBF. HOW MANY OCCURRENCES OF THE DEFECTIVE CUTTER(S)? ONE. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? CABG. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT¿S BODY, AND IF SO HOW WAS IT RETRIEVED? YES, ONE BROKEN PIECE RETRIEVED BY SURGICAL TEAM. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY? NO. WHAT WAS THE PATIENT¿S OUTCOME? NO HARM. WAS THE PROCEDURE COMPLETED AS PLANNED? YES. NO FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17625146 ↗