BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1801462 · Received August 16, 2010

    Report

    Report Number
    3005075853-2010-04658
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 22, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE FIRED THROUGH LOCKOUT THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT TRANSVAGINAL SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT'S BLADDER WAS PERFORATED. THE PERFORATION WAS VISUALIZED DURING CYSTOSCOPY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. IT WAS REPORTED THAT THE PATIENT WILL BE CATHETERIZED FOR ONE WEEK FOLLOWING THE PROCEDURE. NO OTHER TREATMENT WAS ADMINISTERED FOR THE PERFORATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE" AND "DOING WELL".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE CLIPS WERE SCISSORED AND SOME OF THE CLIPS DID NOT ADVANCE INTO THE JAWS PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. RISK MANAGEMENT HAS THE DEVICE AND DOES NOT KNOW WHEN THE DEVICE WILL BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4T18W

    Patients

    Seq Age Sex Outcome Treatment
    1