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AESCULAP PL572TRecalls & reported problems

Aesculap AG · LIGATURE CLIP 12 MAG.= 144 PCS. · Class 2 · Implant

Adverse event reports
16
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04038653208494), received between Feb 10, 2021 and Feb 3, 2022 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (6 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

Device problems

  • Unintended Ejection6
  • Detachment of Device or Device Component4
  • Material Fragmentation2
  • Deformation Due to Compressive Stress1
  • Device Damaged by Another Device1
  • Ejection Problem1
  • Failure to Eject1

Patient problems

  • No Clinical Signs, Symptoms or Conditions16

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 3, 2022Failure to Eject; Failure to Eject

    IT WAS REPORTED TO AESCULAP AG THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # PL572T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, 5 MILLIMETER (MM) CLIPS WERE USED WITH THE DEVICE. THE OPERATOR WAS ABLE TO PLACE THE FIRST CLIP INTO THE PATIENT WITHOUT ISSUE, HOWEVER, WHEN THE NEXT CLIP WAS FIRE, THE ENTIRE MAGAZINE CAME LOOSE IN THE PATIENT'S ABDOMEN. THE MAGAZINE WAS RETRIEVED, AND REATTACHED, BUT WHEN IT WAS RE-TESTED OUTSIDE THE PATIENT, THE MAGAZINE CAME LOOSE. A NEW CLIP MAGAZINE WAS THEN USED. AFTER ATTACHING TO THE PLIERS AND BEING CAREFUL TO FIRMLY SEAT THE MAGAZINE, THE DEVICE WAS TESTED OUTSIDE THE PATIENT, BUT THE ISSUE RECURRED. THE WHOLE MAGAZINE PUSHED AWAY FROM THE PLIERS WHEN THE CLIPS WERE FED AND DETACHED FROM THE FORCEPS. A THIRD MAGAZINE WAS THEN ABLE TO BE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 13445855 ↗
  • MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    UPDATE: THE MALFUNCTION OCCURRED IN THE DEPARTMENT OF UROLOGY, DURING AN UNSPECIFIED PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13043137 ↗
  • MalfunctionSep 21, 2021Unintended Ejection; Unintended Ejection

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL572T - LIGATURE CLIP 12 MAG.= 144 PCS. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE MAGAZINE DETACHED DURING THE SURGERY. THE PRODUCT WAS REPLACED WITH A NEW ONE AND COULD BE USED WITHOUT ANY PROBLEMS. 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. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12510197 ↗
  • MalfunctionSep 16, 2021Unintended Ejection; Unintended Ejection

    IT WAS REPORTED TO AESCULAP AG THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # PL572T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE CLIP MAGAZINE FELL OFF DURING SURGERY. 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 12481102 ↗
  • MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED TO AESCULAP AG THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # PL572T) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING SURGERY, THE TIP OF THE CLIP MAGAZINE BROKE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. A SURGICAL DELAY WAS REPORTED ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4) REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12384003 ↗
  • InjuryAug 26, 2021Unintended Ejection; Unintended Ejection

    CORRECTION: ADDED THE "PRODUCT NAME". IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL572T - LIGATURE CLIP 12 MAG.= 144 PCS..

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12373989 ↗
  • MalfunctionAug 26, 2021Ejection Problem; Ejection Problem

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL572T - LIGATURE CLIP 12 MAG.= 144 PCS.. ACCORDING TO THE COMPLAINT DESCRIPTION, THE MAGAZINE CAME OFF DURING SURGERY. AFTER REPLACING THE MAGAZINE, THE PRODUCT WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12373630 ↗
  • MalfunctionAug 24, 2021Device Damaged by Another Device; Device Damaged by Another Device

    IT WAS REPORTED TO AESCULAP (B)(4) THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # PL572T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIP WAS DAMAGED. THE PLASTIC SITE WAS DAMAGED AFTER THE FIRST FIRE DURING SURGERY. THE COMPLAINT DEVICE HAS 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).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12363136 ↗
  • InjuryAug 24, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    CLARIFICATION: AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12363122 ↗
  • InjuryAug 20, 2021Unintended Ejection; Unintended Ejection

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL572T - LIGATURE CLIP 12 MAG.= 144 PCS. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE CLIPS WAS EJECTED INTO THE PATIENT'S ABDOMEN. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12348683 ↗
  • MalfunctionJul 14, 2021Unintended Ejection; Unintended Ejection

    UPDATE: THIS CASE IS ASSOCIATED WITH FOLLOWING MDR NUMBER 9610612-2021-00500 ((B)(4) PL574T), 9610612-2021-00539 ((B)(4) PL574T), AND 9610612-2021-00501 ((B)(4) PL572T).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12166070 ↗
  • InjuryJun 18, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED TO AESCULAP AG THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # PL572T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGICAL PROCEDURE, AFTER THE SURGEON FIRED THE FIRST SHOT, THE DEVICE WAS REMOVED FROM THE PATIENT AND PART OF THE CLIP MAGAZINE WAS FOUND TO BE BROKEN OFF. FOLLOWUTHE SURGEON SEARCHED THE ABDOMINAL CAVITY, BUT WAS NOT ABLE TO IDENTIFY OR RECOVER THE FRAGMENT. THEREFORE, THE REPORTER INDICATED THE POSSIBILITY THAT THE FRAGMENT REMAINED IN THE BODY. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE XC (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12024852 ↗
  • MalfunctionJun 15, 2021Unintended Ejection; Unintended Ejection

    IT WAS REPORTED TO AESCULAP AG THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # (B)(4)) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE CARTRIDGE OF THE DEVICE CAME OFF DURING SURGERY. WHEN THE DOCTOR ATTACHED THE CLIP TO THE CHALLENGER DEVICE, AND TRIED TO GET THE CLIP TO THE TIP, THE CARTRIDGE CAME OFF. THE SHAPE OF THE MAGAZINE ON THE SIDE WAS DIFFERENT FROM USUAL. THE PHYSICIAN SWITCHED TO ANOTHER CARTRIDGE TO COMPLETE THE PROCEDURE. 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 WAS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12005425 ↗
  • MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO AESCULAP AG THAT A LIGATURE CLIP 12 MAG.= 144 PCS (PART # PL572T) WAS BEING TESTED PRIOR TO USE DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE CLIP WAS JAMMED. WHEN CHECKING THE PRODUCT IN THE PRESENCE OF THE AGENCY, IT WAS SUGGESTED THAT THE PLATE MIGHT RETURN SLOWLY BECAUSE THERE WAS A POSSIBILITY OF EXCESSIVE GAS LEAKING FROM THE APPLIER. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4). INVOLVED COMPONENTS PL575SU - CHALLENGER TI-P CO2-CARTRIDGE O - UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11886899 ↗
  • InjuryMar 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL572T-LIGATURE CLIP 12 MAG.= 144 PCS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIPS DETACHED FROM THE CLAMP IN THE PATIENT'S ABDOMEN. WHEN THE BARRETTE WAS TAKEN, SHE HAS BROKEN. AVAILABLE FOR ANALYSIS. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11426577 ↗
  • InjuryFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    INVOLVED COMPONENTS: PL530R - CLIP APPLIER/REMOVER ANGLE D:12.5/350MM - LOT: UNKNOWN. PL530R - CLIP APPLIER/REMOVER ANGLE D:12.5/350MM - LOT: UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11308926 ↗

Other CLIP, IMPLANTABLE devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.