BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 4850329 · Received June 17, 2015

    Report

    Report Number
    3005075853-2015-03646
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 27, 2015
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID CLIPS FIRE OUT SIDEWAYS? WERE CLIPS FALLING FROM DEVICE OR EJECTED? DID CLIPS FIRE UNFORMED? WERE CLIPS MALFORMED? WERE CLIPS SCISSORED? HOW WAS CASE COMPLETED?

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED EVENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON ACTUATION OF THE DEVICE, THE ADVANCER WAS NOTED TO BE BENT; ON THE SUBSEQUENT ACTUATION THE ADVANCER TIP BROKE, LEADING TO THE MALFORMATION OF THE REMAINING TEN CLIPS. FINALLY, THE INSTRUMENT LOCKED OUT AS INTENDED, HOWEVER THE ORANGE INDICATOR WHEEL DID NOT SHOW UP. A POSSIBLE CAUSE FOR THE CONDITION OF BENT ADVANCER IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE ORANGE INDICATOR WHEEL MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS ARE NOT FIRED PROPERLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394992 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L90E90

    Patients

    Seq Age Sex Outcome Treatment
    1