BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    MDR report key: 2191711 · Received July 1, 2011

    Report

    Report Number
    2647580-2011-00437
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GET
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: 30 MINUTES INTO PROCEDURE, THE DOCTOR DISCOVERED THAT TIP OF THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED. OPERATIVE TIME WAS NOT EXTENDED. NO BLEEDING OCCURRED. NO TISSUE WAS DAMAGED. NOTHING FELL INTO THE PATIENT CAVITY. NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK SINGLE USE LAPAROSCOPIC HAND INSTRU GET USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1