BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3181526 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03172
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 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 WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: AT WHAT FIRING WAS IT NOTICED THAT THE JAWS WERE WOBBLING? -THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WERE THERE ANY UNUSUAL NOISES HEARD? -THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID ANY PART OF THE JAWS FALL OFF OF THE DEVICE AND INTO THE PATIENT? -THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF SO HOW WAS THE PIECE RETRIEVED? -THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THE DEVICE FIRED OVER ANY HARD OBJECTS CAUSING DAMAGE TO THE JAWS OF T HE DEVICE? -THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    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, THE JAW WAS WOBBLING AND THE CLIP WAS NOT FED INTO THE JAWS. 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
    282199 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1