BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17996805 · Received October 24, 2023

    Report

    Report Number
    9610773-2023-03052
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    September 24, 2023
    Report Date
    March 29, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761023658
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: H6, H10 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 DAMAGED/BROKEN TIP ISSUE COULD NOT BE DETERMINED, HOWEVER, IT IS BELIEVED THAT THE DAMAGE WAS THERMALLY MECHANICALLY INDUCED, LIKELY THE RESULT OF MECHANICAL OVERLOAD/SHOCK DUE TO USER HANDLING/MISHANDLING. THE EVENT CAN 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 -- NOT TEETH -- 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.

    Additional Manufacturer Narrative · 0

    G4:K931994/ K931995. DURING EVALUATION, THE FOLLOWING WERE FOUND: THE CERAMIC TIP WAS DAMAGED, AND THE SEALING RING WAS WORN. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS CERAMIC TIP WAS BROKEN. THE ISSUE WAS FOUND DURING REPROCESSING. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788685 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A42011A 19YW 04042761023658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OTV-S190.