BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3043556 · Received April 9, 2013

    Report

    Report Number
    3005075853-2013-01665
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 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 ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? -- 1ST DEVICE: NO / 2ND DEVICE: THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? -- 1ST DEVICE: NO / 2ND DEVICE: THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? -- 1ST DEVICE: YES / 2ND DEVICE: NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ¿ BOTH: NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? ¿ BOTH: NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? -- BOTH: YES. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT (A) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, FED, AND FORMED FOUR CLIPS AS INTENDED, IT EJECTED THREE CLIPS; AND ONE SCISSORED CLIP. WHILE FIRING THE DEVICE THE HANDLES WERE NOTED TO BE SLIGHTLY OPEN. IT IS POSSIBLE THAT THE SEPARATION OF THE HANDLES CAUSED DIFFICULTY TO FIRED THE DEVICE. FINALLY, IT LOCKED OUT AS INTENDED. NO CONCLUSION CAN BE REACHED WHAT CAUSED THE DROPPING AND EJECTED CLIPS AND SCISSORING CLIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. 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. DEVICE B ADDITIONAL INFORMATION: BATCH # K90553, EXPIRATION DATE: 12/2017, MANUFACTURING DATE: 01/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP WAS NOT CLOSED AND FELL OUT FROM THE JAWS WHEN THE DEVICE WAS USED ON THE BLOOD VESSEL. REGARDING THE 2ND DEVICE SCISSORING OCCURRED AFTER THE DEVICE WAS FIRED A FEW TIMES. 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
    147002 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1