BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BLADELESS 5X100 STABILITY

    MDR report key: 2954050 · Received February 11, 2013

    Report

    Report Number
    3005075853-2013-00547
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WERE ANY NOISES HEARD SUCH AS 'WHISTLING' OR 'HISSING'? UNK. IF SO, DID THE 'NOISE' PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. UNK. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? UNK. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? UNK. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? UNK. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? UNK. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS LEAKING. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58051 OPT BLADELESS 5X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1