BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PLUS

    MDR report key: 7138940 · Received December 21, 2017

    Report

    Report Number
    2647580-2017-09059
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 30, 2017
    Report Date
    March 8, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    UDI-DI
    20884521067575
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE PHOTOGRAPH. THE PHOTOGRAPH DEPICTS A CLEAR PLASTIC RING BEING RETRIEVED WITH A GRASPER INSTRUMENT DURING A SURGICAL PROCEDURE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, WHILE IN THE PRE-PERITONEAL SPACE, A CLEAR PLASTIC RING/OBJECT SEPARATED FROM THE DEVICE WHICH FELL INTO THE PATIENT¿S CAVITY AND WAS REMOVED WITH A GRASPER. A NEW DEVICE WAS OPENED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917132 SPACEMAKER PLUS LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO SMBTTRND P7G1237X 20884521067575

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR