AESCULAP PO004RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653260140), received between Feb 10, 2021 and Feb 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Arcing” (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.

• MalfunctionFeb 10, 2021Arcing; Arcing

  IT WAS REPORTED TO AESCULAP INC. THAT METZENBAUM SERRATED SCISSORS (PART # PO004R) WERE USED DURING A UROLOGY PROCEDURE PERFORMED (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SURGEON USED THE SCISSORS WITH A MONOPOLAR CONNECTION TO TAKE DOWN SOME ADHESIONS AND IT ARCED NEAR THE DISTAL END OF THE INSULATION. THE SYSTEM SETTINGS WERE NOTED AS BEING 30 CUT/30 COAG. THE INSULATION PASSED THE INSULATION TEST DURING REPROCESSING PRIOR TO THE CASE. NO INJURIES TO THE PATIENT, THE ARCING HIT THE ABDOMINAL WALL AND NO BOWEL WAS BURNED. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS EVENT. REPOREDLY, THE ARCING HIT THE ABDOMINAL WALL, BUT NO BOWEL BURN OCCURRED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308920 ↗