BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3103260 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02213
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 17, 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). 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

    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?- AT THE 1ST FIRING. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? -- NONE. WHEN THE EVENT OCCURRED, THE DEVICE WAS FIRED OUTSIDE THE PATIENT. 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. IF SO, WHEN? - N/A. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? -- NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? -- YES. WHAT WERE THE INDICATIONS FOR SURGERY? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT WAS FOUND? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF SO, WHAT? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF SO, WHOM? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE CLIP FELL OUT WHEN THE CLIP WAS FED INTO THE JAWS OUTSIDE THE PATIENT. 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
    202875 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H44X0T

    Patients

    Seq Age Sex Outcome Treatment
    1