BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2211506 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03296
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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? ASKU. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC ARTERY & DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? CLIPS FELL FROM JAWS. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? ASKU. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? ASKU. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ASKU. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? ASKU.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED WITH THE CRIMP OUT OF SPECIFICATION CAUSING THAT THE SHROUD SUBASSEMBLY LOSES ITS INTENDED POSITION IN RELATION TO THE SUPPORT TUBE. DUE TO THIS CONDITION THE CLIPS COULD NOT BE FED INTO THE JAWS. A POTENTIAL CAUSE OF THIS CONDITION MAY BE THAT THE CRIMP WAS NOT PROPERLY MADE DURING THE MANUFACTURING PROCESS. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE EVENT REPORTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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 CLIPS WERE FALLING OUT OF THE JAWS OF THE DEVICE. THEY WERE RETRIEVED FROM THE PATIENT. NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H43W32

    Patients

    Seq Age Sex Outcome Treatment
    1