BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2980782 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00876
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AT WHAT FIRING DID THIS OCCUR? - UNKNOWN. WHAT VESSEL WAS THE DEVICE CLOSED ON? - THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. HOW WAS THE DEVICE REMOVED FROM THE VESSEL? - THE DEVICE WAS PULLED OUT. WAS THERE ANY TISSUE DAMAGE? IF YES PLEASE EXPLAIN HOW THE TISSUE WAS REPAIRED? - YES. THE DAMAGED VESSEL WAS STOPPED BLEEDING BY ELECTRICAL SCALPEL. WAS THERE ANY BLOOD LOSS? IF SO HOW MUCH BLOOD LOSS? - YES. SMALL AMOUNT OF BLOOD. DID THE PATIENT RECEIVE ANY BLOOD PRODUCTS? IF SO HOW MUCH? - NO. ANY TORQUE OR TWISTING DURING THE FIRING OF THE DEVICE? - NO. ANY UNUSUAL NOISES HEARD DURING CLOSING , FIRING OR ATTEMPTING TO OPEN THE DEVICE? - THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? - THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IT IS POSSIBLE THAT THE DRIED BODY FLUIDS COULD HAVE PREVENTED TO PROPER FEEDING OF THE CLIP INTO THE JAW. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN MEDIASTINAL NEOPLASM PROCEDURE, THE JAWS COULD NOT BE OPENED WHEN THE DEVICE WAS USED ON THE BLOOD VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WHEN THE SALES REP RECEIVED THE DEVICE, IT WAS FOUND THAT MALFORMED CLIP (J-LIKE FORM) WAS BEING FED INTO THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84921 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1