AESCULAP PM433RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653208654), received between Apr 14, 2021 and Nov 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PM433R-JAW INS.BIP.MACRO FORCEPS D:5/310MM. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT DURING A HYSTERECTOMY SURGERY ON (B)(6) 2021 THE DOCTOR NOTICED THAT ALTHOUGH THE DEVICE PM403R MAKE THE USUAL SOUNDS AND PRODUCE WARM FROM THE BIPOLAR GENERATOR. THE FORCEPS ITSELF DOESN'T FUNCTION AS THEY SHOULD BE. AS THE PROXIMAL END BASE GOT WARM INSTEAD OF THE FORCEPS ITSELF. THE DOCTOR SWITCHED TO A ANOTHER CABLE (GN133) AND THE PROBLEM CONTINUED. THE DOCTOR DECIDED TO CONTINUE THE SURGERY WITHOUT THE PM403R. THE PATIENT HAS NO INJURIES AT ALL AND THEY MANAGED TO COMPLETE THE OPERATION SUCCESSFULLY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PM973R-INSULATED OUTER TUBE 5/5MM 310MM-UNKNOWN. PM450R-HANDLE FOR BIPOLAR INSTRUMENTS-UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749140 ↗
• MalfunctionApr 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A JAW INS.BIP.MACRO FORCEPS D:5/310MM (PART # PM433R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE CERAMIC CRACKED INSIDE THE GRASPING FORCEPS. FOLLOWING THE PROCEDURE, DURING THE PRE-STERILIZATION INSPECTION, THE CERAMIC CRACK INSIDE THE GRASPING FORCEPS WAS IDENTIFIED. NO POWER FAILURE OCCURRED DURING USE. THERE WERE NO NOTABLE DIFFICULT SCENES DURING THE OPERATION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ALTHOUGH REQUEST, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664838 ↗