BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 20274402 · Received September 20, 2024

    Report

    Report Number
    9610773-2024-02286
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Report Date
    October 4, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020961
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: H6(COMPONENT CODE IS BEING CORRECTED TO 3123 - TIP). CORRECTION IS BEING MADE TO PREVIOUSLY SUBMITTED G3 - DATE RECEIVED BY MANUFACTURER. THE CORRECT DATE WAS 09/05/2024. ADDITIONAL INFORMATION ADDED TO FIELD D8,H3,H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 12 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, THE REPORTED DAMAGE PATTERN INDICATE THAT THE DAMAGE WAS THERMALLY AND MECHANICALLY INDUCED; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL PMA/510(K) NUMBER: K931995.

    Description of Event or Problem · 0

    THE USER FACILITY RETURNED A RESECTION SHEATH, 24 FR. TO THE SERVICE CENTER. DURING INSPECTION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE CERAMIC TIP BROKE OFF OF THE RESECTION SHEATH. THE CUSTOMER DID NOT REPORT ANY PATIENT INVOLVEMENT OR HARM TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309605 RESECTION SHEATH, 24 FR. HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A22041A 121W-0049 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown