BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** MCA CLIP APPLIER

    MDR report key: 2792405 · Received October 16, 2012

    Report

    Report Number
    3005075853-2012-04740
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    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). ADDITIONAL INFORMATION REQUESTED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? ASKU. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ASKU. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? UNKNOWN. WAS THERE ANY TORQUE OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? UNKNOWN. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNKNOWN. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS TESTED FOR CONTINUITY AND WAS FOUND TO BE CONFORMING. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. NO CONCLUSION COULD BE DRAWN AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL THYROIDECTOMY PROCEDURE, THE DEVICE WOULD NOT PRODUCE CLIPS. THE DEVICE RIPPED THE VESSEL INSTEAD AND CAUSED BLEEDING. THE AMOUNT OF BLOOD LOSS IS LESS THAN 250CC. NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS DELAYED ONE TO TWO MINUTES. NO CLIPS WOULD COME OUT. ANOTHER CLIP WAS USED TO REPAIR THE RIP AND TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** MCA CLIP APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA J4C17A

    Patients

    Seq Age Sex Outcome Treatment
    1