AESCULAP PL430RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653347957), received between Dec 31, 2021 and Aug 9, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2023Break; Break

  THIS REPORT IS SUBMITTED IN REFERENCE TO MW5119092. IT WAS REPORTED TO AESCULAP INC. THAT AN ENDOSCOPIC MYOMA FIXATION INSTRUMENT (MATERIAL # PL430R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, DURING THE SURGEYR, THE TIP OF MYOMA SCREW BROKE. FRAGMENTS DETACHED INTO THE PATIENT, BUT ALL WERE SUCCESSFULLY RETRIEVED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT YET BEEN MADE AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491984 ↗
• InjuryAug 9, 2023Break; Break

  UPDATE: PATIENT HARM WAS CONFIRMED AS ADDITIONAL MEDICAL INTERVENTION. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491983 ↗
• InjuryDec 31, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED TO AESCULAP (B)(4) THAT AN ENDOSCOPIC MYOMA FIXATION INSTRUMENT (PART # PL430R) WAS USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 5 MILLIMETER (MM) LAPAROSCOPIC MYOMA SCREW BROKE LEAVING A FRAGMENT EMBEDDED IN A UTERINE FIBROID INSIDE THE PATIENT. SNAPPED INSIDE UTERINE FIBROID. THE SHAFT OF THE INSTRUMENT WAS REMOVED IMMEDIATELY AND THE BROKEN PIECE OF THE SCREW WAS REMOVED SHORTLY AFTER. THE EVENT HAPPENED TOWARD THE END OF THE PROCEDURE AND LUCKILY DID NOT CAUSE HARM TO THE PATIENT. ROUGHLY 20 MINS OPERATING TIME WAS ADDED TO THE PROCEDURE DUE TO THE NEED TO RETRIEVE THE BROKEN INSTRUMENT AND ENSURE ALL PARTS WERE REMOVED. 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 (B)(4) REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125547 ↗