BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 18610491 · Received January 30, 2024

    Report

    Report Number
    9610773-2024-00296
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 5, 2024
    Report Date
    August 8, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4) PMA/510(K) NUMBER: K931994/K931995 ( NOTING DUE TO CHARACTER LIMIT) THE DEVICE WAS NOT RETURNED TO OLYMPUS, AND IT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION OF THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, ASSOCIATED H6 CODING AND AN UPDATE TO B5, H2 AND H3 BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, THE PRODUCT WAS NOT RETURNED TO OLYMPUS, NO PHYSICAL EQUIPMENT INSPECTION WAS DONE. IT IS LIKELY THE DAMAGE TO THE CERAMIC BEAK OF THE SHEATH WAS CAUSED BY THERMAL AND MECHANICAL INDUCED IMPACT, WEAR AND TEAR, IMPROPER HANDLING, MECHANICAL OVERLOAD LIKE FALL, SHOCK OR SIMILAR STRESS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE ISSUE CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS PROVIDED IN: THE IFU CARRIES A WARNING THAT THE CERAMIC TIP CAN BREAK DUE TO MECHANICAL LOADING OR THERMALLY INDUCED STRAINING. THUS, IT IS THE RESPONSIBILITY OF THE USER TO INSPECT THE INSTRUMENT PRIOR TO EVERY PROCEDURE: ¿4 BEFORE USE WARNING INFECTION CONTROL RISK PROPERLY REPROCESS THE PRODUCT BEFORE FIRST AND EACH SUBSEQUENT USE FOLLOWING THE INSTRUCTIONS IN THIS MANUAL AND IN THE SYSTEM GUIDE ENDOSCOPY. IMPROPER AND/OR INCOMPLETE REPROCESSING CAN CAUSE INFECTION OF THE PATIENT AND/OR MEDICAL PERSONNEL. 4.1 INSPECTION AND TESTING INSPECTING THE PRODUCT VISUALLY INSPECT THE PRODUCT. MAKE SURE THAT IT HAS: -- NO CORROSION -- NO DENTS -- NO SCRATCHES CERAMIC INSULATION AT DISTAL END VISUALLY INSPECT THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END BEFORE EACH USE. DO NOT USE THE INSTRUMENT IN CASE OF DAMAGE (E.G. CRACKS, FRACTURES). WARNING RISK OF INJURY IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END. DAMAGED INSTRUMENTS CAN CAUSE INJURIES TO THE PATIENT AND/OR USER. DO NOT USE THE INSTRUMENT IF DAMAGED. DAMAGED PRODUCT IF THE PRODUCT IS DAMAGED OR DOES NOT FUNCTION PROPERLY, CONTACT AN OLYMPUS REPRESENTATIVE OR AN AUTHORIZED SERVICE CENTER.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CERAMIC TIP OF THE INNER SHEATH, FOR 26 FR. OUTER SHEATH WAS DAMAGED. THIS OCCURRED TOWARDS THE END OF A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE(TURP). THE PROCEDURE WAS COMPLETED WITH NO DELAY, USING THE REPORTED DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383203 INNER SHEATH, FOR 26 FR. OUTER SHEATH INNER SHEATH, FOR 26 FR HIH OLYMPUS WINTER & IBE GMBH A22040A 182W-0168 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown