BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

    MDR report key: 18081000 · Received November 6, 2023

    Report

    Report Number
    9610773-2023-03193
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 6, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761023658
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4:K931994/ K931995. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH IS BEING SUPPLEMENTED WITH ADDITIONAL INFORMATION OBTAINED AND THE MANUFACTURER'S FINAL INVESTIGATION RESULTS. THE DEVICE WAS NOT RETURNED TO THE LEGAL MANUFACTURER FOR EVALUATION. INVESTIGATION IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. IN ADDITION TO THE REPORTED EVENT, THE HANDLE OF THE TENSION RING WAS DETACHED. THE CAUSE OF THE REPORTED ISSUE IS LIKELY IMPROPER HANDLING BY THE USER DURING REPROCESSING. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. 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: THE INSTRUCTIONS FOR USE STATE: ¿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 THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH HAD A BROKEN END. THE ISSUE WAS FOUND DURING REPROCESSING. THE DEFECT WAS DUE TO CUSTOMER MISHANDLING. THERE WAS NO PROCEDURE INVOLVED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349880 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS HYSTEROSCOPE HIH OLYMPUS WINTER & IBE GMBH A42011A 175W-0057 04042761023658

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown