BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2250116 · Received September 15, 2011

    Report

    Report Number
    3005075853-2011-03818
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAW. ADDITIONAL INFORMATION WAS REQUESTED. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. DURING TESTING THE DEVICE FIRED CLIPS WITH A GAP. IT WAS IDENTIFIED THAT THIS WAS A RESULT OF THE CLIP TIPS BEING LOCATED OUTSIDE THE JAW POCKETS DURING THE FORMING OF THE CLIPS. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE JAWS WERE NOTED TO BE OUT OF SPECIFICATIONS LEADING THE MALFORMED CLIPS. THE CLIP IS DESIGNED SUCH THAT THE CLIP TIPS CLOSE TOWARD EACH OTHER (TERMED "TIP-TO-TIP") AND FORM A DIAMOND SHAPE DURING INITIAL CLIP FORMING. AS THE CLIP CONTINUES TO FORM, THE DIAMOND SHAPE IS FLATTENED UNTIL THE LEGS OF THE CLIP ARE ESSENTIALLY PARALLEL TO EACH OTHER. THE DESIGN INTENT OF THE FORMING SYSTEM IS TO ENSURE THAT THE FORMED CLIP REMAINS WITHIN THE JAW POCKETS DURING FINAL CLIP FORMING. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. IN ORDER TO AVOID THAT THE CUSTOMER EXPERIENCED, PRIOR TO POSITIONING THE JAWS AROUND THE TUBULAR STRUCTURE OR VESSEL; LOAD A CLIP INTO THE JAWS BY PARTIALLY SQUEEZING THE TRIGGER IN A SMOOTH CONTINUOUS MOTION FOR APPROXIMATELY ONE-THIRD OF THE TOTAL FIRING STROKE. INSPECT THE JAW TIPS TO ENSURE THE CLIP IS FULLY ADVANCED IN THE JAWS. COMPLETE THE FIRING CYCLE BY SQUEEZING THE TRIGGER UNTIL IT STOPS AGAINST THE HANDLE TO COMPLETELY FORM THE CLIP ON THE TARGETED STRUCTURE OR VESSEL. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS NOT FIRING CORRECTLY, THE DEVICE IS JAMMING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1