BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK

    MDR report key: 4902420 · Received July 9, 2015

    Report

    Report Number
    2647580-2015-00486
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    May 15, 2015
    Report Date
    September 3, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GET
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION RECEIVED ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT, AND AN EVALUATION OF THE RETURNED DEVICE. THE SHAFT WAS OBSERVED TO HAVE DISCOLORATION ALONG ITS LENGTH. THE ROTATION KNOB FUNCTIONED WITHOUT DIFFICULTY. THE JAWS COULD NOT BE EXTENDED OR RETRACTED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED AS A RESULT OF THE ALLEGED EVENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.(B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SILS OP. ACCORDING TO THE REPORTER: AT THE PRODUCTS THE ISOLATION IS BROKEN AT THE PLACE WHERE INSTRUMENT CAN BE BENDED. THEREFORE PARTIALLY NO CLOSURE OF THE BRANCHES POSSIBLE. NEW INSTRUMENT WAS USED. NO PERSON INJURED, NO EXTENSION OF OP, NO BLOOD LOSS, NO EXTENSION OF INCISION, NO CHANGE OF OP, NO LOSS OR DAMAGE TO TISSUE, NO REINFORCEMENT MATERIAL USED. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444713 ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED GET COVIDIEN, FORMERLY USSC PUERTO RICO INC 174233 P5B0241X

    Patients

    Seq Age Sex Outcome Treatment
    1