BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTICULATOR ENDO MINI-SHEARS 5MM INSTR.

    MDR report key: 1791761 · Received August 3, 2010

    Report

    Report Number
    2647580-2010-00677
    Event Type
    Injury
    Date Received
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K914752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE PLASTIC COVERING THE ROTICULATED INNER SHAFT HAD MELTED AND CAUSED A BURN ON THE LIVER. THE SURGEON NOTICED THE HOT SPOT ON THE DEVICE, KEPT IT AWAY FROM TISSUE, AND CONTINUED WITH THE SAME INSTRUMENT. THERE WAS NO FURTHER SURGICAL INTERVENTION REQUIRED FOR THE DAMAGE TO THE LIVER. THE DEVICE GENERATED THE HEAT WHICH RESULTED IN THE BURN. THERE WERE NO OTHER CAUTERY DEVICES USED DURING THE PROCEDURE. A GRASPING DEVICE WAS ALSO USED DURING THE PROCEDURE. THIS EVENT DID NOT RESULT IN LOSS OF TISSUE. THERE WERE NO FURTHER DEVICE ISSUED NOTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO MINI-SHEARS 5MM INSTR. DISPOSABLE SURGICAL ACCESSORY GCJ USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other