BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 18133613 · Received November 14, 2023

    Report

    Report Number
    9610773-2023-03289
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 26, 2023
    Report Date
    July 19, 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
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4:K931994/ K931995. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. 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.   CORRECTION ON FIELDS: G2 (HEALTH PROFESSIONAL WAS INADVERTENTLY UNSELECTED I N THE PREVIOUS REPORT). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THAT THE DAMAGE OF THE INSULATION MATERIAL OF THE SHEATH WAS CAUSED BY IMPROPER HANDLING, APPLICATION OF EXCESSIVE FORCE, MECHANICAL IMPACT LIKE FALL, SHOCK OR SIMILAR STRESS, THERMAL MECHANICAL OVERLOAD. ADDITIONALLY, IT CAN BE ASSUMED THE INSULATION TIP'S DAMAGE WAS CAUSED BY MECHANICAL THERMAL INFLUENCE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU): 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

    THE CUSTOMER REPORTED TO OLYMPUS, THE INNER SHEATH, FOR 26 FR. OUTER SHEATH CERAMIC TIP WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    THE ISSUE WAS FOUND BEFORE THE DIAGNOSTIC CYSTOSCOPY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977866 INNER SHEATH, FOR 26 FR. OUTER SHEATH HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A22040A 23734 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown