BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18120287 · Received November 13, 2023

    Report

    Report Number
    9610773-2023-03260
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 24, 2023
    Report Date
    June 27, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761023658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G3: K931994/ K931995. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE GUIDE SCREW WAS RUSTY AND FRACTURE WITHIN THE THREADS, WHICH COULD NOT BE REMOVED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE EVENT OF THE BROKEN SHEATH TIP WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS PRESUMED THAT THE DAMAGE OCCURRED DUE TO THERMO-MECHANICAL FATIGUE. THE THE ROOT CAUSE OF THE DAMAGE COULD NOT BE SPECIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR USE (IFU): IFU STATES THE DETECTION METHOD IN GIF/CF/PCF-290 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION IFU STATES THE PREVENTATIVE MEASURES IN GIF/CF/PCF-290 SERIES OPERATION MANUAL 3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM: NOTHING OTHER THAN STERILE WATER SHOULD BE USED FOR AIR/WATER FEEDING. NO ADDITIVES SHOULD BE PUT INTO THE STERILE WATER. NON-STERILE WATER MAY CAUSE PATIENT CROSS-CONTAMINATION AND/OR INFECTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH HAD A BROKEN CERAMIC TIP. 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
    2162051 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A42011A 176W 04042761023658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown