BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNER SHEATH FOR 27050 SL

    MDR report key: 22311540 · Received June 23, 2025

    Report

    Report Number
    2020550-2025-01012
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 23, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIH
    UDI-DI
    04048551078136
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WILL NOT BE RETURNED FOR INVESTIGATION TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ACCORDING TO THE INITIAL INFORMATION, THE INSTRUMENT BROKE DURING SURGERY. ADDITIONAL INFORMATION RECEIVED ON JUNE 13,2025: DETAILED EVENT DESCRIPTION RECEIVED FROM KSE KOREA: "TOWARD THE END OF THE SURGERY, DURING PREPARATION FOR COAGULATION, CUTTING LOOP 011160-01 WAS BEING REPLACED WITH 011169-01.THE PROCEDURE INVOLVED DISCONNECTING A WORKING ELEMENT THAT WAS ASSEMBLED WITH 27050SL AND 27050XA. DURING THE DISCONNECTION PROCESS, THE ROTATING PART OF THE 27050XA (INNER SHEATH) WAS FOUND TO BE TORN. AS A RESULT, THE TIP OF THE CUTTING LOOP WAS CAUGHT IN THE SHEATH AND BROKE OFF, CAUSING DEVICE DAMAGE. TO EXAMINE THE SURGICAL SITE, THE ENDOSCOPE WAS REINSERTED, AND FRAGMENTS OF THE TORN SHEATH AND THE BROKEN TIP OF THE CUTTING LOOP WERE FOUND INSIDE THE BLADDER. DURING THE REMOVAL OF THESE FRAGMENTS, AN INJURY OCCURRED, RESULTING IN A BLADDER TEAR." IT WAS FURTHERMORE STATED THAT THE PATIENT WAS IMMEDIATELY TRANSFERRED (B)(6) HOSPITAL AND IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607874 INNER SHEATH FOR 27050 SL INNER SHEATH FOR 27050 SL HIH KARL STORZ SE & CO. KG 27050XA 04048551078136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H ARTICLE: 011160-01| ARTICLE: 011169-01| ARTICLE: 27050SL| ARTICLE: WORKING ELEMENT (ARTICLE-NO. UNKNOWN)