BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2220005 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03443
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? EVERY 3RD OR 4TH CLIP. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC DUCT & ARTERY. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? ASKU. 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. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? CONTINUED TO USE.

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY, CAM. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED EMPTY AND WITH A CAM RAMP DAMAGED. THE JAW/CAM WAS VISUALLY INSPECTED AND NO BURR WAS NOTED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE JAW/CAM APERTURE WAS MEASURED AND IT WAS NOTED WITHIN MANUFACTURING SPECIFICATION. POSSIBLE CAUSES FOR DAMAGED CAM MIGHT BE TWISTING OF THE JAWS, FORCE PLACED ON THE JAWS DURING ACTIVATION OR EXCESSIVE LOADING DUE TO FORMING A CLIP OVER ANOTHER DEVICE EXCEEDING THE STRUCTURAL CAPABILITY OF THE JAWS AND/OR CAM. 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 SINGLE SITE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE SPRINGING OUT/SHOOTING OUT OF THE JAWS. THEY WERE RETRIEVED. SOME OF THE CLIPS WERE IN "P" SHAPE. THEY CONTINUED TO USE THE DEVICE 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