BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPERATING CYSTOSCOPE-URETHROSCOPE

    MDR report key: 16503003 · Received March 8, 2023

    Report

    Report Number
    9610617-2023-00040
    Event Type
    Death
    Date Received
    March 8, 2023
    Date of Event
    January 30, 2023
    Report Date
    March 1, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGB
    PMA / PMN Number
    K940464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND PHYSICAL INSPECTION WERE PERFORMED. THE OPTIC WAS EXAMINED IN DETAIL AND DAMAGE WAS FOUND AT THE DISTAL END. THE DISTAL SOLDER SEAM IS CHEMICALLY ATTACKED AND PARTIALLY DISSOLVED, RESULTING IN LEAKAGE OF THE IMAGING SYSTEM. FURTHERMORE, NOTCHES AND IMPACTS CAN BE SEEN IN THE DISTAL EDGE AREA OF THE OPTIC. THE SHAFT SHOWS MINIMAL DEFORMATION. PROXIMALLY, THE OPTIC IS IN GOOD GENERAL CONDITION. THE OPTIC WAS MICROBIOLOGICALLY SAMPLED BY THE U.S. DEPARTMENT OF HEALTH DUE TO THE INFECTION THAT UNFORTUNATELY LED TO THE PATIENT'S DEATH. NO MICROBIOLOGICAL CONTAMINATION WAS DETECTED.. PRODUCT HISTORY WAS ALSO REVIEWED AND FOUND NO DEVIATION. THIS COMPLAINT WILL CONTINUE TO BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    RECEIVED AN UPDATE REPORT FROM HEALTH DEPARTMENT INDICATED THERE WAS NO GROWTH OF P. AERUGINOSA. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MDR INCORRECTLY LISTS THE CLASSIFICATION PRODUCT CODE AS ODB, AND IT ALSO INCORRECTLY LISTS 510K NUMBER K943697. THE OPERATING CYSTOSCOPE-URETHROSCOPE MODEL # R27030KAK WAS CLEARED UNDER THE 510K NUMBER IS K940464, AND THE CORRECT CLASSIFICATION PRODUCT CODE IS FGB.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION /INVESTIGATION RESULTS BECOME AVAILABLE, SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN EVENT WITH A 27030KAK OPERATING CYSTOSCOPE-URETHROSCOPE. ACCORDING TO THE INFORMATION RECEIVED, BOTH CYSTOSCOPES AND URETEROSCOPE WERE USED IN THIS CASE. CYSTOSCOPY WAS BEING PERFORMED. PER THE SITE, THEY STATED THAT THERE WASN'T ANYTHING UNUSUAL NOTED DURING THE CASE. CASE WAS COMPLETED WITHOUT ANY ISSUE. THERE WAS NO MALFUNCTION OF THE DEVICE DURING THE CASE. PATIENT DEVELOPED AN INFECTION WITHIN A 48-HOUR PERIOD AND HAD TO GO BACK TO THE HOSPITAL FOR TREATMENT. PATIENT SUBSEQUENTLY PASSED ON (B)(6) 2023 DUE TO COMPLICATIONS FROM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037144 OPERATING CYSTOSCOPE-URETHROSCOPE SEMI-RIGID FGB KARL STORZ SE & CO. KG R27030KAK
    1776752 OPERATING CYSTOSCOPE-URETHROSCOPE SEMI-RIGID FGB KARL STORZ SE & CO. KG R27030KAK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Death