BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT* II 10MM INSTRUMENT

    MDR report key: 5820159 · Received July 25, 2016

    Report

    Report Number
    2647580-2016-00522
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 5, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K920068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN THE DEVICE WAS USED FOR KIDNEY RETRACTION, THE SIDE PART WAS BROKEN. THE SURGEON SAID THAT HE OR SHE USED THE DEVICE WHILE TWISTING IT. THE EVENT OCCURRED IN USE FOR PATIENT. THE SURGICAL TIME WAS NOT EXTENDED. THE STATUS OF THE PATIENT: NO PROBLEM. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PRODUCT WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473098 ENDO RETRACT* II 10MM INSTRUMENT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC 176647 P6A0166X

    Patients

    Seq Age Sex Outcome Treatment
    1