BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPE SHEATH, REUSABLE

    MDR report key: 17671662 · Received September 1, 2023

    Report

    Report Number
    9610617-2023-00229
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    July 25, 2023
    Report Date
    December 12, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIH
    UDI-DI
    04048551007228
    PMA / PMN Number
    K221893
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED ON 2023-09-07. THE INVESTIGATION OF THE PRODUCT WAS COMPLETED ON 2023-11-29. THE EVALUATION OF THE PRODUCT REVEALED THAT THE ARTICLES IN QUESTION WERE REPAIRED BY A THIRD PARTY. IT IS THEREFORE VERY LIKELY THAT THE EXTERNAL COMPANY DID NOT FULFILL KARL STORZ'S QUALITY REQUIREMENTS. AT THE DISTAL END, THE SHAFT OF TWO ARTICLES WAS MOST LIKELY MACHINED TOO MUCH, SO THAT THE WALL OF THE TUBE WAS TOO THIN AND THE CONNECTION BETWEEN THE CERAMIC BEAK AND THE TUBE WAS NO LONGER GIVEN. ON THE THIRD SHANK THERE IS NO RECOGNIZABLE GLUE RESIDUE, WHICH HAS RESULTED IN THE CERAMIC BEAK HAVING NO CONNECTION TO THE SHANK. THE MISSING CONNECTION BETWEEN THE CERAMIC BEAK AND THE SHANK, CAUSED THE CERAMIC TO FALL OFF. AS DESCRIBED IN THE IFU THAT THE ARTICLES NEEDS TO BE CHECKED FOR INTACTNESS BEFORE USE, THESE DAMAGES SHOULD HAVE BEEN NOTICED, THEREFORE, APART FROM THE EXTERNAL REPAIR, A USER ERROR IS NOT EXCLUDED. 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. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LASER AURIGA 30 FRAGMENTATION OF A LARGE BLADDER STONE WITH THE STORZ RESECTOR, THE CERAMIC TIP BROKE OFF AND PASSED INTO THE BLADDER. THIS FORCED THE SURGEON TO DO A LAPAROTOMY TO RECOVER THE PART INSIDE THE LAVA. THE CERAMIC COMPLETELY SEPARATED FROM THE SHEATH AND PASSED INTO THE BLADDER. THE SURGERY WAS PROLONGED FOR 1H 30 MINUTES. THE RESECTION OF THE PROSTATE WAS RESCHEDULED 15 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249845 ENDOSCOPE SHEATH, REUSABLE INNER SHEATH FOR RESECTOSCOPE HIH KARL STORZ SE & CO. KG 26050CA ST01 04048551007228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention