BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3052103 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01718
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 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 FOUND THAT THE DEVICE 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 AND FED AND FORMED FIVE SCISSORED CLIPS, AND THEN THE REMAINING CLIPS WERE FORMED AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THE CLIP "SCISSORED?" -- YES. WAS THE JAWS MISALIGNED? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID CLIPS FALL INTO THE PATIENT? -- YES. IF YES, HOW WAS IT RETRIEVED? WITH A FORCEPS VIA A TROCAR. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? SECOND. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. 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. THERE WAS AN UNEXPECTED FEELING (MOVING OVER) IN THE HANDLE. 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? THE DOCTOR TRIED TO FIRE THE DEVICE OUTSIDE THE PATIENT, BUT IT COULD NOT BE FIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DISTAL PART OF THE CLIP COULD NOT BE CLOSED AND IT WAS MISALIGNED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154639 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CD5H

    Patients

    Seq Age Sex Outcome Treatment
    1