BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 18123155 · Received November 13, 2023

    Report

    Report Number
    9610773-2023-03264
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Report Date
    April 22, 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
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    G3: K931994/ K931995. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. 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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED, HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED DAMAGED CERAMIC TIP COULD NOT BE DETERMINED, HOWEVER, BASED ON A PICTURE OF THE DAMAGED TIP, THE ISSUE WAS CONFIRMED AND IT WAS DETERMINED THAT THE DEVICE WAS REPAIRED BY A THIRD PARTY USING ADHESIVE AND THE CERAMIC TIP THEN CAME LOOSE FROM THE SHAFT. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: "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

    THE CUSTOMER REPORTED TO OLYMPUS, THE INNER SHEATH, FOR 26 FR. OUTER SHEATH BROKE OFF AT CERAMIC TIP. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126259 INNER SHEATH, FOR 26 FR. OUTER SHEATH HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A22040A UNKNOWN 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown