BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3241164 · Received July 22, 2013

    Report

    Report Number
    3005075853-2013-03670
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? -2ND FIRING. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? -CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? -NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ¿NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ¿NO. WERE ANY UNEXPECTED NOISES HEARD? -NO. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? ¿NO. DID THE CLIP FEED SIDEWAYS, SLOWLY OR NOT FEED INTO THE NOSE OF THE DEVICE? ¿THE CLIP DIDN¿T FEED INTO THE JAWS, BUT IT WAS NOT PROVIDED FROM THE HOSPITAL HOW THE CLIP FED INTO THE JAWS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. THE JAWS WERE FOUND PROPERLY ALIGNED. IN AN ATTEMPT TO REPLICATE THE INCIDENT REPORTED THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED AND THEN, IT LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSE THE FOUND CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A TEARDROP-SHAPED CLIP WAS FORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341642 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1