BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1962190 · Received January 17, 2011

    Report

    Report Number
    3005075853-2011-00222
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    November 24, 2010
    Report Date
    December 23, 2010
    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 WITH ONE JAW BROKEN AT BIFURCATION. THE REMAINING CLIPS WERE EJECTED DUE TO THE FOUND CONDITION OF THE JAW. EVIDENCES OF CORROSION ON THE BROKEN AREA WERE NOTED. THE MOST LIKELY REASON FOR JAW BIFURCATION BREAKAGE IS STRESS CORROSION CRACKING AND THE MOST LIKELY ROOT CAUSE IS EXPOSURE TO A SOLUTION CONTAINING CHLORINE. THIS CONDITION IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER POST-SURGERY DEVICE CLEANING. THE JAW BREAKAGE IS NOT OCCURRING AS A RESULT OF THE PRODUCT COMPLAINT DECONTAMINATION PROCESS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MISFIRED. THE CLIPS WERE NOT CLOSING PROPERLY AND THE NEXT FIRING THE DEVICE JAMMED AND WOULD NOT RELEASE OFF THE CYSTIC DUCT. THEY PRIED THE HANDLES OPEN TO REMOVE IT FROM THE TISSUE. NO TISSUE TRAUMA NOTED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    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