BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 19919606 · Received August 6, 2024

    Report

    Report Number
    9610773-2024-01891
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 14, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    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

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PMA/510(K) NUMBER: K931994/K931995.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, IT WAS PRESUMED THAT THE EVENT OCCURRED DUE TO THERMALLY AND MECHANICALLY INDUCED DAMAGE. IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE DAMAGE OR WEAR TO THE INSULATING INSERT, OR WHETHER THE DAMAGE WAS TRIGGERED DURING THE LAST PREPARATION CLEANED, DISINFECTED, STERILIZED (CDS) OF THE INSTRUMENT OR DURING THE LAST PROCEDURE. HOWEVER, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CERAMIC TIP OF THE SHEATH WAS DAMAGED. THE ISSUE OCCURRED DURING A THERAPEUTIC PROSTATE PLASMA ELECTROCAUTERY. THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662104 INNER SHEATH, FOR 26 FR. OUTER SHEATH HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A22040A 21109 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OTV-S7V - VISERA VIDEO SYSTEM CENTER| OTV-S7V-VISERA VIDEO SYSTEM CENTER