BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSCOPE ONLY FOR MIP L

    MDR report key: 19175977 · Received April 24, 2024

    Report

    Report Number
    9610617-2024-00116
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 4, 2024
    Report Date
    July 1, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGA
    UDI-DI
    04048551366660
    PMA / PMN Number
    K940594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE INFORMATION PROVIDED BY THE CUSTOMER CAN BE CONFIRMED. DUE TO THE MISSING OR DISSOLVED DISTAL SOLDER SEAM AND THE LOSS OF THE DISTAL COVER GLASS, THE ROD LENS SYSTEM HAS CLEARLY PROTRUDED FROM THE SYSTEM TUBE. THE INVESTIGATION REVEALED THAT THE PROCESS CHEMICALS USED, AND THEIR EXPOSURE TIME CAUSED THE SOLDER SEAM TO DISSOLVE AND THE COVER GLASS TO FALL OUT. THIS ALLOWED THE ROD LENS SYSTEM TO ESCAPE FROM THE SYSTEM TUBE AND MOISTURE TO PENETRATE THE EXPOSED ROD LENS SYSTEM. THE DEFECT WAS CAUSED BY INCORRECT REPROCESSING OR INCORRECT PROCESS CHEMICALS AND INCORRECT EXPOSURE TIME (USER ERROR). THE DAMAGE IS NOT DUE TO A PRODUCTION ERROR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OBJECTIVE LENS COME OUT FROM TIP DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ON APRIL 15, 2024 WE GOT NEW INFORMATION, THAT DURING PROCEDURE THE LENS FALL OUT INSIDE PATIENT BODY AND CAUSED A PROLONGATION FOR MORE THAN 60 MINUTES. IT IS UNCLEAR IF THE SEPARATED PART COULD BE RETRIEVED. THEREFORE, AS A PRECAUTION, THE CASE IS DEEMED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515381 NEPHROSCOPE ONLY FOR MIP L NEPHROSCOPE FGA KARL STORZ SE & CO. KG 27840KA 1003RC 04048551366660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other