AESCULAP PL569TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04038653181353), received between Apr 23, 2021 and Mar 8, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO AESCULAP AG THAT A LIGATING CLIPS M/L 12/BOX (PART # PL569T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT VERBALLY CONTACTED TORONTO HUMANE SOCIETY (THS) WITH REGARDS TO PRODUCT. IT WAS POTENTIALLY USED DURING A PROCEDURE IN (B)(6) 2015. PATIENT REPORTED FEELING UNWELL SINCE THIS TIME. PATIENT HAS REQUESTED FURTHER INFORMATION WITH REGARDS TO THE MANUFACTURER/COMPOSITION OF PRODUCT IN ORDER TO PROCEED WITH FURTHER TESTING THROUGH HIS/HER PHYSICIAN. THS HAS NOT RECEIVED A COMPLAINT FROM THE HOSPITAL WITH REGARDS THE PRODUCT. PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 16507189 ↗
• InjuryFeb 11, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED TO AESCULAP AG THAT A LIGATING CLIPS M/L 12/BOX (PART # PL569T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE FIRST TWO (2) TO THREE (3) CLIPS WORKED FINE, BUT THEN THE MAGAZINE WAS PUSHED AWAY FROM THE CLIP BAR (PART # PL538R) AT THE NEXT ACTIVATION. THIS HAPPENED INSIDE THE PATIENT'S ABDOMEN. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT WAS NOT INJURED. HOWEVER, AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PL538R - SHAFT COMPL.D:10MM L:260MM - LOT UNKNOWN. PL510R - HANDLE F/PL506R & PL508R - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517269 ↗
• MalfunctionNov 19, 2021Material Separation; Material Separation

  IT WAS REPORTED TO AESCULAP AG THAT A LIGATING CLIPS M/L 12/BOX (PART # PL569T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS COMPRESSED, THE TOP BROKE OFF AND ENDED UP IN THE PATIENT. THE FRAGMENT WAS RETRIEVED AND THEN THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, 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 12844614 ↗
• InjuryApr 23, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED TO AESCULAP AG THAT A LIGATING CLIPS M/L 12/BOX (PART # PL569T) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIPS FELL IN SITU. REPORTEDLYM, AFTER THE THIRD OR FOURTH CLIP HAD BEEN PLACED, THE COMPLETE MAGAZINE SUDDENLY DETACHED INTO THE ABDOMINAL CAVITY AND HAD TO BE RETRIEVED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: PL510R - HANDLE F/PL506R & PL508R - LOT UNKNOWN. PL536R - SHAFT COMPL.D:10MM L:370MM - LOT 62424289.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720789 ↗