BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPE, URETEROSCOPE

    MDR report key: 2071845 · Received April 22, 2011

    Report

    Report Number
    1418479-2011-00007
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 22, 2011
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    FGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: REPAIR OF THE DEVICE BY OTHER REPAIR SERVICE. EVAL SUMMARY: USER FACILITY RETURNED THE ENDOSCOPE FOR REPAIR AND EVAL. VISUAL INSPECTION OF THE ENDOSCOPE SHOWED NON-RICHARD WOLF COMPONENTS, OBJECTIVE LENSES. THE ENDOSCOPE HAD VERY LIMITED VIEW. THE ILLUMINATION FIBER LIGHT WAS APPROX 40%. THE ENDOSCOPE WAS PURCHASED BY THE FACILITY ON (B)(4) 2003. THE ENDOSCOPE WAS FOUND TO BE UN-REPAIRABLE AND WILL BE DISCARDED. CUSTOMER IS PURCHASING A NEW ENDOSCOPE. CAUSSE OF EVENT: DEVICE MAINTENANCE CONTRIBUTED TO THE EVENT. DEVICE MAINTAINED BY OTHER THAN RICHARD WOLF REPAIR SERVICE.

    Description of Event or Problem · 1

    DURING URETEROSCOPY, 0.035 GUIDEWIRE WAS PLACED IN THE LEFT RENAL PELVIS. A RIGHT ENDOSCOPE WAS PASSED INTO THE LEFT URETERAL OFFICE WITH THE ASSISTANCE OF AN 0.035 GUIDEWIRE THROUGH SCOPE. IT WAS ADVANCED TO THE LEVEL OF THE URETEROPELVIC JUNCTION. AN ATTEMPT TO PASS A URETERAL SHEATH OVER SUPER RIGID GUIDEWIRE FAILED. WITH THE RIGID GUIDEWIRE IN PLACE, AN ATTEMPT WAS MADE TO PASS AN ACMI SCOPE OVER THE WIRE. THE SCOPE WAS UNABLE TO PASS BEYOND THE VESSELS. THE RIGID SCOPE WAS REPLACED AND AN ATTEMPT WAS MADE TO PASS THE SCOPE PAST THE URETEROPELVIC JUNCTION. THE URETER HAD A KINK AT THE LEVEL OF THE URETEROPELVIC JUNCTION. THE SCOPE COULD NOT EASILY BE PASSED. THE 0.035 GUIDEWIRE HAD DOUBLED BACK ON ITSELF AND FIXED SOMEHOW TO THE SCOPE. THE SCOPE WAS REMOVED AND IN THE REMOVAL OF THE SCOPE, THE URETER WAS AVULSED. THE PT WAS TAKEN TO SURGERY, WHERE A NEPHRECTOMY WAS PERFORMED. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPE, URETEROSCOPE ENDOSCOPE, URETEROSCOPE FGB RICHARD WOLF MEDICAL INSTRUMENTS 8703.402

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention