BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3242721 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03685
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE ELECTRODE MISSING AND NOT RETURNED; THE ELECTRICAL CABLE WAS CUT OFF. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND EVIDENCE OF THE ACTIVE ROD WAS SEEN. BECAUSE OF THE MISSING ELECTRODE AND CABLE CUT OFF WE WERE UNABLE TO TEST THE FULL FUNCTIONALITY OF THE INSTRUMENT. IT IS POSSIBLE THAT A REPLACE INSTRUMENT WAS NOTED DURING USAGE WITH THE JAW DAMAGED IN THIS MANNER. THIS WAS NOT CONFIRMED DURING COMPLAINT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, A METAL PIECE OF THE INNER SIDE OF THE JAWS WENT LOOSE. YOU'LL FIND THE PIECE IN THE PACKAGE THAT IS SENT BACK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344494 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4CU6D

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR