BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDB

    MDR report key: 8824400 · Received July 24, 2019

    Report

    Report Number
    2647580-2019-03852
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 24, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GEX
    UDI-DI
    20884521067940
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    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 LAPAROSCOPIC CRYOTHERAPY OF LEFT KIDNEY, RETROPERITONEAL BALLOON DID NOT EXPAND. THE PHYSICIAN CHECKED FOR DEFECTS AND PROPER CONNECTION OF THE PUMP AND ATTEMPTED TO INFLATE OUTSIDE THE BODY BUT STILL IT WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616431 PDB LASER INSTRUMENT, SURGICAL, POWERED GEX US SURGICAL PUERTO RICO OMS-PDBS2 P7D0184X 20884521067940

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR