BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2792427 · Received October 16, 2012

    Report

    Report Number
    3005075853-2012-04744
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    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). ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON?---UNK. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ---AROUND THE CHOLECYST. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? ---NO INFORMATION. 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? YES. WERE ANY UNEXPECTED NOISES HEARD? ---NO IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ---NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ---NO INFORMATION. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? --- THE PROCEDURE NAME WAS NOT LAR BUT CHOLECYSTECTOMY. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? ---NO INFORMATION. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? ---NO INFORMATION. THE DEVICE WAS RETURNED FOR ANALYSIS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY IT CYCLED AND FED SEVEN CONFORMING CLIPS THEN IT DID LOCKOUT WITHOUT ANY DIFFICULTIES NOTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THERE WAS AN UNEXPECTED RESISTANCE IN GRASPING THE TRIGGER. THERE WAS A GAP BETWEEN THE FIRED CLIP. 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
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J91NOM

    Patients

    Seq Age Sex Outcome Treatment
    1