BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 19838740 · Received July 26, 2024

    Report

    Report Number
    9610773-2024-01814
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 14, 2024
    Report Date
    October 25, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. E1/ESTABLISHMENT NAME: THE FIRST MEDICAL CENTER OF THE GENERAL HOSPITAL OF THE CHINESE PEOPLE'S LIBERATION ARMY. ADDED HERE DUE TO CHARACTER LIMITATION IN RESPECTIVE FIELD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED LOOSE/DETACHED CERAMIC TIP ISSUE COULD NOT BE DETERMINED, HOWEVER, THE ISSUE WAS LIKELY THERMALLY MECHANICALLY INDUCED AND THE RESULT OF WEAR AND OR IMPACT STRESS SUCH AS A SHOCK/FALL DUE TO USER HANDLING/MISHANDLING. THE EVENT MAY BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: 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 THE GYNECOLOGY HYSTEROSCOPE CERAMIC TIP WAS LOOSE AND FELL OFF. THE ISSUE OCCURRED DURING REPROCESSING OF CYSTOSCOPY PROCEDURE. THE FACILITY FINISHED THE PROCEDURE WITH THE SAME DEVICE WITHOUT ANY PROCEDURAL DELAY AND THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914126 INNER SHEATH, FOR 26 FR. OUTER SHEATH GYNECOLOGY HYSTEROSCOPE HIH OLYMPUS WINTER & IBE GMBH A22040A 156W-0157 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown VISERA ELITE VIDEO SYSTEM CENTER