BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4103017 · Received September 19, 2014

    Report

    Report Number
    3005075853-2014-06531
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 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
    KY, US
    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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MANY ER320 DEVICES HAD ISSUE OF SCISSORED CLIPS (ONE DEVICE, TWO DEVICES, THREE DEVICES)? PLEASE PROVIDE SPECIFIC NUMBER OF DEVICES THAT HAD ISSUE WITH SCISSORED CLIPS. WERE ALL DEVICES WITH SCISSORED CLIPS DISPOSED OF? HOW MANY DEVICES ARE YOU REQUESTING BE REPLACED FOR CUSTOMER, ONE DEVICE, TWO DEVICES, OR THREE DEVICES? TWO DEVICES HAD SCISSORED CLIPS PER REP. A THIRD DEVICE WAS USED TO COMPLETE THE CASE. ALL THREE DEVICES DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE ACCOUNT SAID THAT THE DEVICE'S CLIPS SCISSORED. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER TWO DEVICES OF THE SAME PRODUCT CODE. THREE DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582178 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1