BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BLADELESS 5X100 STABILITY

    MDR report key: 3170645 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03030
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED: PLEASE CLARIFY WHAT PART OF THE TROCAR BENT. TOP OF SHAFT. DID ANY PART OF THE TROCAR BREAK OFF ? NO. DID ANY PIECE OF THE DEVICE FALL INTO THE PATIENT? NO. IF SO HOW WAS THE PIECE OF THE DEVICE RETRIEVED? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUESTS FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR WAS INSERTING THE DEVICE WHEN HE PUSHED DEVICE INTO THE PATIENT IT BENT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271582 OPT BLADELESS 5X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4CD5R

    Patients

    Seq Age Sex Outcome Treatment
    1