BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOSCOPE 15FR X 37MM ADULT

    MDR report key: 10288902 · Received July 17, 2020

    Report

    Report Number
    9610617-2020-00080
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    April 29, 2020
    Report Date
    July 16, 2020
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FBO
    PMA / PMN Number
    K945185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE WAS SAMPLED TO DETERMINE IF CONTAMINATION WAS PRESENT IN THE CHANNEL WHEN RETURNED FROM THE CUSTOMER. THE RESULTS OF THE SAMPLE IDENTIFIED THREE MICROORGANISMS, WHERE ONLY ONE OF WHICH, CHRYSEOBACTERIUM, IS POTENTIALLY CONSIDERED OF HIGH CONCERN BASED ON MORPHOLOGY(I.E. GRAM NEGATIVE, ROD). EACH MOCROORGANISM GREW IN LOW NUMBERS WITH 1 COLONY FORMING UNIT(CFU) BEING RECORDED PER ISOLATE. IT COULD NOT BE CONFIRMED WHETHER THE ORGANISMS IDENTIFIED MATCH THOSE LINKED TO PATIENT INFECTIONS AS THIS INFORMATION WAS NOT PROVIDED. THE ORGANISMS OF LOW CONCERN, MICROCOCCUS LUTEUS AND DERMACOCCUS NISHINOMIYAENSIS, MOST LIKELY RESULTED FROM AN EXTERNAL SOURCE OF CONTAMINATION(E.G. LABORATORY SAMPLING)BASED ON THEIR TYPICAL ENVIRONMENTAL SOURCE (E.G. HUMAN SKIN). ALTHOUGH LABORATORY TESTS PERFORMED ON THE RETURNED PRODUCTS IDENTIFIED A SINGLE HIGH CONCERN ORGANISM FOLLOWING RETURN TO KARL STORZ, NO MICROBIOLOGICAL CONTAMINATION WERE IDENTIFIED AFTER STANDARD REPROCESSING. THIS INDICATES THAT THERE MAY BE GAPS IN THE EXISTING REPOCESSING METHODS BY THE CUSTOMER. STANDARD REPROCESSING AS PERFORMED IN THE EVALUATION CENTER AT KSE-CHARLTON RESOLVED THE CONTAMINATION AND INDICATES THAT NO MAJOR CONTAMINATION ISSUES/BIOFIL FORMATION IS PRESENT. COMPLIANCE WITH THE STANDARD, VALIDATED PROCEDURE FOR REPROCESSING OF KARL STORZ FLEXIBLE ENDOSCOPES ENSURES PATIENT SAFETY. BASED ON THIS INVESTIGATION, THIS SCOPE PASSED ALL OUTGOING INSPECTION REQUIREMENT AND THE DEVICE HISTORY RECORD DID NOT CONTAIN ANY ANOMALIES THAT WOULD CONTRIBUTE TO THE FAILURE IN THE FIELD. THE IFU HAS STATEMENTS REGARDING PROPER DISINFECTION AND STERILIZATION OF THE DEVICE PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN ANY ADDITIONAL INFORMATION FROM THE CUSTOMER. THE SCOPE WAS RETURNED AND FOUND OVER BEND OF THE PASSIVE SECTION OF THE VERTEBRAE SYSTEM AND THE MARKER RINGS ON SHAFT ARE DISCOLORED YELLOW. ADDITIONALLY, THE TAPER ASSEMBLY IS BURNT. THE FACILITY RECEIVED THE PRODUCT ON 02/20/2020. THE ENDOSCOPE HAS BEEN SAMPLED FOR TESTING AND SENT TO THE LABORATORY AND ARE WAITING FOR RESULTS.

    Description of Event or Problem · 1

    ALLEGEDLY PER THE CUSTOMER, REPORTS OF BACTERIAL INFECTIONS OCCURRED POST-OPERATIVE ON SEVERAL OCCASIONS DURING THE MONTHS OF (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755128 CYSTOSCOPE 15FR X 37MM ADULT CYSTOSCOPE FBO KARL STORZ SE & CO. KG 11272CK2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention