AESCULAP PL579TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963398835), received between Mar 26, 2021 and Dec 27, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Unintended Ejection; Unintended Ejection

  IT WAS REPORTED TO AESCULAP INC. THAT A CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR. (PART# PL579T) WAS USED DURING A BARIATRIC GASTRIC BYPASS ON DECEMBER 06 2023. ACCORDING TO THE COMPLAINANT THE CLIP APPLIER SUCCESSFULLY FIRED AND CLIPPED TWICE. FURTHER USE OF THE CLIP APPLIER CAUSED THE CLIPS TO BACK UP IN CARTRIDGE. REPORTEDLY THE STAFF TRIED AGAIN TO ENGAGE THE CLIP APPLIER AND 3 TITANIUM CLIPS DROPPED INTO THE PATIENT. THE PIECES WERE RETRIEVED DURING SURGERY AND REMOVED FROM INSIDE OF PATIENT. A DELAY OF TWENTY MINUTES WAS REPORTED AS A RESULT OF THIS INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (2916714-2023-00125) PL520R, (B)(4) (2916714-2023-00127) PL536R.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405707 ↗
• InjuryFeb 17, 2022Unintended Ejection; Unintended Ejection

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR (PART # PL579T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE IS USED IN LAPAROSCOPIC CHOLECYST RESECTION PROCEDURES.THE PROBLEM ENCOUNTERED WAS THE DISLOCATION OF THE CLIP BLISTER (PL579T) FROM THE INSTRUMENT, WHEN USING THE DEVICE. WHEN APPLYING THE SECOND / THIRD CLIP, THE HANDLING MECHANISM JAMS AND THIS BLOCKAGE CAUSES THE BLISTER TO DISLODGE AND FALL IN THE PATIENT'S ABDOMEN. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A SURGICAL DELAY OF FIFTEEN (15) MINUTES WAS REPORTED. 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). INVOLVED COMPONENTS: PL606R - MULTIF.CLIP APPL.TI-P 10/370MM F/ML-CLIP - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550337 ↗
• MalfunctionFeb 3, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR. (PART # PL579T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE CLIPS PUSHED AMONG THEMSELVES DURING SURGERY. THE COMPLAINT DEVICE HAS NOT BEEN 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). INVOLVED COMPONENTS: PL536R - SHAFT COMPL.D:10MM L:370MM - LOT: 62463532; PL520R - CHALLENGER TI-P HANDLE - LOT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444660 ↗
• MalfunctionNov 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL579T - CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CARTRIDGE TIP BROKE DURING SURGERY. THE PATIENT HARM IS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12762902 ↗
• InjuryOct 29, 2021Ejection Problem; Ejection Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR (PART # PL579T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE CLIP WAS DAMAGED DURING SURGERY. REPORTEDLY, THE CLIP RAMP OPENED DURING THE SECOND APPLICATION AND BECAME DETACHED FROM THE REUSABLE GRIPPER. RISK OF BLEEDING FROM VESICULAR INJURY IN THE HEPATHIC PEDICLE. THE USER EXPERIENCED DIFFICULTY STORING THE CLIP RAMP AND PULLING IT OUT THROUGH THE LAPAROSCOPY TROCARS. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. PATIENT HARM IS UNKNOWN. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4) REFERENCE (B)(4).

  Patient problems: Insufficient Information; Liver Laceration(s)

  MAUDE report 12719874 ↗
• MalfunctionJul 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED TO AESCULAP AG THAT A CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR (PART # PL579T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE CLIP PIN BROKE AND DETACHED INTO THE PATIENT. THE PART WAS NOT ABLE TO BE RECOVERED. THE FRAGMENT REMAINED IN SITU. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12159154 ↗
• InjuryMay 18, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL579T-CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TIP OF THE MAGAZINE BREAKS OFF INTRAOPERATIVELY IN SITU. COULD BE RECOVERED. 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 / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11841563 ↗
• InjuryMar 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL579T - CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIP DARTRIDGE FELL INTO PATIENTS´S BODY. WHEN THE MAIN BODY SHAFT WAS PULLED OUT FROM THE TROCAR, THE CARTRIDGE FELL INTO THE PATIENT'S BODY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574636 ↗