AESCULAP PM431RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653208630), received between Apr 8, 2021 and Dec 1, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 18, 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.

• InjuryDec 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM (PART # PM431R) WAS USED DURING A LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A TINY PART OF THE JAW INSERT BROKE OFF AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT, AND THEN THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. NO MENTION OF ANY DELAY IN SURGERY. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909606 ↗
• InjuryDec 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM (PART # PM431R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A TINY PIECE OF THE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT, AND THEN THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909239 ↗
• InjuryApr 8, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM (PART # PM431R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING USE, THE CERAMIC PART OF THE DEVICE BROKE AND DETACHED INTO THE PATIENT'S BODY. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT, AND THEN THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE XC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638373 ↗