BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 2153690 · Received July 7, 2011

    Report

    Report Number
    3005075853-2011-02791
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE REP: I HAVE REACHED OUT TO THE SURGEON. HE DOESN'T TALK MUCH TO INDUSTRY. I HAVE ALREADY TOUCHED BASE WITH THE STAFF TO GET THE INFORMATION I CALLED IN. THE ONLY QUESTION I CAN ANSWER IS THE ACCOUNT DOES NOT REPROCESS THIS DEVICE. MESSAGE FROM REP: I FOLLOWED UP WITH THE NURSE IN THE CASE AND SHE DIDN'T HAVE ANY ADDITIONAL INFORMATION. TO DATE, THE SURGEON HAS NOT RESPONDED TO EES. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH ONE JAW BROKEN AT MIDDLE MAKING THE INSTRUMENT NON-FUNCTIONAL. DRIED BODY FLUIDS AT SHAFT DISTAL AND HANDLE AREA WERE NOTED. EVIDENCE OF CORROSION WAS NOTED ON THE JAW BROKEN AREA. THE JAW BROKE IN A LOCATION SLIGHTLY PROXIMAL OF THE RAMP AND PERPENDICULAR TO THE LENGTH OF THE JAW. AN EXAMINATION AT HIGHER MAGNIFICATIONS SHOWED THAT THE FRACTURE SURFACE CONSISTED OF DUCTILE DIMPLES. THIS OCCURS WHEN A LOAD IS APPLIED TO THE PART THAT EXCEEDS THE STRENGTH OF THE METAL AND THE PART BREAKS IN A DUCTILE MANNER. THERE WERE NO DETECTABLE DEFECTS OBSERVED ALONG THE SIDE OF THE JAW THAT WOULD INDICATE THAT A DEFECT WAS PRESENT ALONG THE PART WHICH WOULD HAVE LOWERED THE STRENGTH OF THE JAW. THIS PART DID NOT BREAK AS A RESULT OF A BRITTLE CONDITION OR FROM AN ENVIRONMENTAL CONDITION SUCH AS STRESS CORROSION CRACKING. IT IS UNCLEAR WHAT CONDITION OCCURRED THAT WOULD RESULT IN THE JAW TO FRACTURE. NO MATERIAL OR PROCESSING DEFECTS WERE OBSERVED ON THE JAW THAT WOULD HAVE LOWERED THE STRENGTH OF THE COMPONENT. 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 ASSISTED VAGINAL HYSTERECTOMY. THE JAW BROKE OFF INSIDE PATIENT AND COULD NOT BE LOCATED. THE JAW WAS LEFT INSIDE THE PATIENT. THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other