BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4220978 · Received November 3, 2014

    Report

    Report Number
    3005075853-2014-07570
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 17, 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
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW DID CLIPS NOT DO TASK EFFECTIVELY? CLIPS DID NOT CLOSE SAFE, CAME CROSSED AND DID NOT HOLD THE VESSEL. WERE CLIPS MALFORMED?- AFTER FIRING CLIPS WERE MALFORMED. DID CLIPS FALL OFF OF BILE DUCT? NO. PLEASE DESCRIBE SPECIFIC ISSUE WITH CLIPS/DEVICE.- CLIPS DID NOT CLOSE SAFE, CAME CROSSED AND DID NOT HOLD THE VESSEL. HOW WAS CASE COMPLETED? SALES REP INDICATED THAT CASE WAS COMPLETED WITH ANOTHER SAFE CLIPS WHICH BELONGS TO DIFFERENT COMPANY, NOT WITH JNJ¿S PRODUCT IS DEVICE BEING RETURNED FOR ANALYSIS? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, THE CLIPS, WHICH FIRED TO BILE DUCT, DID NOT DO ITS TASK EFFECTIVELY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703312 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EV1N

    Patients

    Seq Age Sex Outcome Treatment
    1