BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3964459 · Received July 29, 2014

    Report

    Report Number
    3005075853-2014-05313
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 25, 2014
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? WAS THE USER ABLE TO FIRE THE DEVICE? IF THE DEVICE WAS FIRED, WAS THE CLIP FORMED PROPERLY? WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? THE ANALYSIS RESULTS FOUND THAT THE ER420 DEVICE WAS RECEIVED WITH ONE CLIP BETWEEN THE JAWS AND A BAG WITH TWO MALFORMED CLIPS WAS RETURNED ALONG WITH THE INSTRUMENT. THE CLIP WAS REMOVED IN ORDER TO MEASURE JAW WIDTH. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 AN UNKNOWN PROCEDURE THE DEVICE COULD NOT APPLY CLIPS SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441151 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1