BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1933235 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07266
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH ONE MALFORMED CLIP ATTACHED TO THE TYVEK. FURTHER EVALUATION FOUND THAT ONE JAW WAS BROKEN AT BIFURCATION, THE DEVICE WAS EMPTY AND THE ORANGE INDICATOR WAS OVER TRAVELED. ALTHOUGH, NO TESTING COULD BE PERFORMED TO EVALUATED THE INCIDENT REPORTED, POSSIBLE CAUSES OF MALFORMED CLIPS MIGHT BE EXCESSIVE TWISTING OR TORQUE OF THE DEVICE JAWS WHEN POSITIONING OR FIRING OF THE DEVICE, EXCESSIVE SIDE LOAD APPLIED TO THE JAWS CAUSING THEM TO PARTIALLY COLLAPSE OR PUSHING WITH EXCESSIVE FORCE ON THE PROXIMAL END OF THE DEVICE. IN ADDITION, THE MOST LIKELY REASON FOR JAW BIFURCATION BREAKAGE IS STRESS CORROSION CRACKING AND THE MOST LIKELY ROOT CAUSE IS EXPOSURE TO A SOLUTION CONTAINING CHLORINE. THIS CONDITION IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER POST-SURGERY DEVICE CLEANING. THE JAW BREAKAGE IS NOT OCCURRING AS A RESULT OF THE PRODUCT COMPLAINT DECONTAMINATION PROCESS. HOWEVER, THE FOUND CONDITION OF THE JAWS AND THE INDICATOR FAILURE ARE NOT RELATED WITH THE INCIDENT REPORTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE CLIPS WERE NOT CLOSING COMPLETELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4U54A

    Patients

    Seq Age Sex Outcome Treatment
    1