BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUNKNOWN

    MDR report key: 16769075 · Received April 19, 2023

    Report

    Report Number
    1221826-2023-00082
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 10, 2023
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    PMA / PMN Number
    K141250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MODEL NUMBER AND SERIAL NUMBER WERE NOT PROVIDED. WE, THEREFORE, USED PRODUCT CODE 'FGB' FOR THIS CASE. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    BASED ON THE LACK OF INFORMATION PROVIDED SPECIFIC TO PART NUMBER AND SERIAL NUMBER, ROUTINE INVESTIGATION ACTIVITIES COULD NOT BE PERFORMED. NOT A MANUFACTURING OR DESIGN RELATED ISSUE. IN ADDITION, BASED ON LACK OF INFORMATION PROVIDED, ADDITIONAL ACTION CANNOT BE TAKEN. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    AS PER MEDWATCH REPORT MW5115649 RECEIVED VIA EMAIL FROM THE FDA ON 3-20-2023: I HAD A PERSONAL EXPERIENCE OF INFECTION WITH KARL STORZ SALES REP ENDOSCOPE PROBE VIA UNETHICAL PRACTICES. THE SALES REP (B)(6) USES THE MEDICAL DEVICES PERSONALLY AGAINST COMPANY PROTOCOL, HE THEN SELLS AND SAMPLES AT HOSPITALS (B)(6) AND OTHER INSTITUTIONS. PERSONAL USE ON ANIMALS AT HIS HOME (PROBES ANIMAL ORIFICE), USES THE PROBES IN ATTIC AND WALLS FOR IMAGING, PLAYS WITH THEM WITH VARIOUS FOOD AND VEGETABLES EVEN ROTTING, STORES THEM ON THE FLOOR AND IN VARIOUS PLACES AGAINST STORAGE AND STERILIZATION RULES. PATIENTS IN UROLOGY AND MOSTLY WOMEN HAVE HAD INFECTIONS AND EMAILS WERE SENT TO HIS MANAGER KARL STORZ (B)(6). NO CORRECTIVE ACTION OR ACCOUNTABILITY. CAN BE VERIFIED VIA SERIAL NUMBERS SHIPPED TO SALES REP (B)(6) AND PATIENTS WITH PROCEDURES BETWEEN (B)(6) 2020 TO PRESENT DAY. MANUAL, STORAGE, STERILIZATION PROCEDURES ARE ON KARL STORZ WEBSITE AND WERE NOT FOLLOWED IN MANY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602119 FUNKNOWN UNKNOWN FGB KARL STORZ ENDOVISION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other