BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 8188042 · Received December 20, 2018

    Report

    Report Number
    2951238-2018-00784
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 30, 2016
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO FAJ AND 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    THE LEGAL DOCUMENT DID NOT SPECIFY A MODEL, SERIAL OR LOT NUMBER FOR ANY OF THE DEVICES THAT ALLEGEDLY ATTRIBUTED TO THE PATIENT¿S OUTCOME. THEREFORE, IT IS UNKNOWN IF THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, SERVICE OR REPAIR. IN ADDITION, AS PART OF OUR INVESTIGATION OLYMPUS FOLLOWED UP WITH (B)(6) AND WAS INFORMED BY THE FACILITY¿S VICE PRESIDENT OF QUALITY MANAGEMENT THAT THE FACILITY DOES NOT USE OLYMPUS EQUIPMENT AND THEREFORE, CANNOT PROVIDE ANY DETAILS REGARDING THE MENTIONED PATIENT OR PROCEDURE. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    ON (B)(6) 2018, OLYMPUS RECEIVED A LEGAL DOCUMENT THAT ALLEGES DURING A CYSTOSCOPY WITH URETHRAL DILATION AND TRANSURETHRAL RESECTION/ABLATION OF PROSTATE WITH BIPOLAR PROCEDURE, A PATIENT SUSTAINED A THERMAL INJURY TO THE BLADDER AND URETHRA. ACCORDING THE LEGAL DOCUMENT, THE PATIENT WAS UNDER ANESTHESIA WHEN THE ALLEGED INJURY OCCURRED. IT IS UNKNOWN IF THE PATIENT WAS TREATED OR IF INTENDED PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026382 VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability