BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP APPLIER

    MDR report key: 5449179 · Received February 19, 2016

    Report

    Report Number
    3005075853-2016-01076
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 27, 2016
    Report Date
    February 5, 2016
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. HOW DID CLIPS NOT LOAD PROPERLY? DID CLIPS ONLY SLOW FEED? OR DID CLIPS ALSO SIDEWAYS FEED? OR DID MULTIPLE CLIPS FEED? OR DID DEVICE PARTIALLY FEED CLIPS? OR DID CLIPS DROP AND EJECT?

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # = K92029. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY EVALUATED. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND THE REMAINING 12 CLIPS WERE EJECTED; FINALLY THE INSTRUMENT LOCKED OUT AS INTENDED. NO SLOW FEEDING ISSUES WERE NOTED DURING ANALYSIS. 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 WAS LOADING EXTREMELY SLOW. THE CLIPS WERE ALSO NOT LOADING PROPERLY FORMING MALFORMED CLIPS. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106005 ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4D89R

    Patients

    Seq Age Sex Outcome Treatment
    1