BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB

    MDR report key: 10787886 · Received November 4, 2020

    Report

    Report Number
    3011050570-2020-00137
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    September 14, 2020
    Report Date
    February 3, 2021
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CUSTOMER RESPONSE AND UPDATES. PHOTO OF THE SUBJECT DEVICE WAS PROVIDED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATES ON DEVICE MODEL. SPL-SR' UPDATED TO 'SPL-PR150 IN SECTION D4.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE SUBJECT DEVICE WAS NOT MADE AVAILABLE TO OLYMPUS FOR EVALUATION. UPON REVIEW OF PROVIDED PHOTOS, THE COMPLAINT WAS CONFIRMED. THE PROBE FRACTURE NEAR THE BRAZE JOINT AT THE PROXIMAL END OF THE DEVICE, DISTAL TO THE THREADED CONNECTOR. REVIEW OF DEVICE HISTORY RECORDS (DHR) RECORDS SHOWED THAT ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. BASED ON AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED. HOWEVER, FRACTURE OF THE PROBE IS OFTEN A RESULT OF USER MISHANDLING DURING USE. THE PROBE MUST BE KEPT CONCENTRIC TO THE ENDOSCOPE'S INSTRUMENT CHANNEL WHILE ACTIVE TO PREVENT THE INTRODUCTION OF UNNECESSARY TORQUE ON THE PROBE. PER IFU(INSTRUCTION FOR USE) : THE PROBE IS FRAGILE. IT IS CRITICAL THAT THE SURGEON DOES NOT BEND OR TORQUE THE PROBES AGAINST THE ENDOSCOPE DURING THE PROCEDURE. THERE IS NO NEED TO ROTATE THE PROBE OR TRANSDUCER; IT WILL NOT IMPROVE FRAGMENTATION OR STONE CLEARANCE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    UPDATED INFORMATION : PROBE BROKE DURING ONE PROCEDURE ONLY, NOT TWO.THE PROCEDURE PERFORMED WAS A RIRS PUJ (PELVIC URETERIC JUNCTION) STONE CASE USED WITH 8 FR WOLF SEMI RIGID URETEROSCOPE.THERE WAS A DELAY IN THE PROCEDURE APPROXIMATELY 5 MINUTES WITH NO HARM TO THE PATIENT. INTENDED PROCEDURE WAS COMPLETED WITH A BACK UP SIMILAR DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSTOMY (URS) PROCEDURE THE DEVICE PROBE BROKE. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THE EVENT. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. NO PATIENT INJURY OR HARM WAS REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250756 SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-PR150

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 8FR WOLF URETEROSCOPE.| 8FR WOLF URETEROSCOPE