BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE VIDEO CYSTOSCOPE

    MDR report key: 7418124 · Received April 10, 2018

    Report

    Report Number
    1221826-2018-00028
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 12, 2018
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FBO
    UDI-DI
    04048551226193
    PMA / PMN Number
    K062918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT EVALUATION CONCLUDED THE FOLLOWING: THERE IS DEBRIS ON DISTAL LENS AND DISTAL TIP OF THE SCOPE, ANGLE COVER IS CRACKED AND HAS DEBRIS ON IT. THE SHAFT MARKER RINGS ARE DISCOLORED. A NICK WAS FOUND ON THE HANDLE HOUSING. THE EVALUATION RESULTS SUGGEST THAT USER ERROR CAN BE LINKED TO THE PHYSICAL CONDITION OF THE INSTRUMENT. THE PHYSICAL EVALUATION OF THE FLEXIBLE VIDEO CYSTOSCOPE FOCUSED ON SCOPE DAMAGE AND WHETHER IT COULD HAVE AN IMPACT ON PATIENT INFECTIONS. THE PRESENCE OF DEBRIS CAN HARBOR ORGANISMS THAT CAN LEAD TO CROSS CONTAMINATION BETWEEN PATIENTS. DAMAGE SUCH AS SCRAPES IN THE CHANNEL CAN CONTRIBUTE TO INFECTIONS; THE DAMAGED AREA CAN HARBOR ORGANISMS THAT REDUCE THE EFFICACY OF CLEANING AND SUBSEQUENT REPROCESSING STEPS. IN ORDER TO PERFORM A MICROBIOLOGICAL ASSESSMENT OF THE VIDEO CYSTO URETHROSCOPE (11272VNU, S/N (B)(4)), ENDOSCOPE CHANNEL SAMPLING WAS PERFORMED AT OUR IN-HOUSE LABORATORY AND THE RESULTANT EXTRACT WAS SUBMITTED FOR MICROBIAL ANALYSIS ON APRIL 6, 2018. MULTIPLE LOCATONS AT THE CUSTOMER SITE WERE SAMPLED IN ORDER TO HELP DETERMINE THE SOURCE OF THE CAUSATIVE ORGANISM; STERILE GLOVES, TUBES, SAMPLE CONTAINERS, AND WATER FOR IRRIGATION WERE USED. THE SAMPLES WERE SUBMITTED TO NELSON LABORATORIES TO SPECIFICALLY DETERMINE IF P. AERUGINOSA WAS PRESENT. THE FINAL RESULTS CONFIRM THAT THE CAUSATIVE ORGANISM (P. AERUGINOSA) WAS NOT PRESENT IN THE SAMPLES ANALYZED. THE INVESTIGATION REFLECTS THERE IS NO DIRECT LINK BETWEEN THE SCOPE USE/REPROCESSING AND THE PATIENT INFECTIONS AS THE CAUSATIVE ORGANISM WAS NOT RECOVERED FROM ANY SAMPLE LOCATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT EVALUATION CONCLUDED THE FOLLOWING: THERE IS DEBRIS ON DISTAL LENS AND DISTAL TIP OF THE SCOPE, ANGLE COVER IS CRACKED AND HAS DEBRIS ON IT. THE SHAFT MARKER RINGS ARE DISCOLORED. A NICK WAS FOUND ON THE HANDLE HOUSING. THE EVALUATION RESULTS SUGGEST THAT USER ERROR CAN BE LINKED TO THE PHYSICAL CONDITION OF THE INSTRUMENT. INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PHYSICIAN PERFORMED A CYSTOSCOPY PROCEDURE ON PATIENT. PATIENT'S URINE WAS CULTURED AND PSEUDOMONAS AERUGINOSA INFECTION WAS CONFIRMED FROM THE LAB RESULTS. PATIENT WAS TREATED WITH ANTIBIOTICS FROM A DOCTOR OUTSIDE OF THE CLINIC. THE DOCTOR REPORTED THAT PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260505 FLEXIBLE VIDEO CYSTOSCOPE FLEXIBLE VIDEO CYSTOSCOPE FBO KARL STORZ ENDOVISION 11272VNU 04048551226193

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other