BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4232010 · Received November 6, 2014

    Report

    Report Number
    3005075853-2014-07671
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 21, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED PARTIALLY CYCLED AND WITH A CLIP IN THE JAWS; THE CYCLED WAS COMPLETED AND ONE CONFORMING CLIP WAS FED. 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; HOWEVER, DURING THE ANALYSIS THE ANTI-BACKUP FEATURE WAS FOUND TO BE NON-FUNCTIONAL. THE DEVICE WAS DISASSEMBLED IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS AND THE ANTI-BACKUP LEVER WAS FOUND TO BE DAMAGED; NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS CONDITION. 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, THE JAWS DID NOT OPEN AFTER A NURSE FIRED THE DEVICE FOR FUNCTIONALITY. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714690 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EMOP

    Patients

    Seq Age Sex Outcome Treatment
    1