BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 19940615 · Received August 8, 2024

    Report

    Report Number
    9610773-2024-01921
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PMA/510(K) NUMBER: K931994/K931995. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO CERAMIC TIP WAS REPAIRED BY THE THIRD PARTY WITH BAD IMPROPER ADHESIVES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR

    Description of Event or Problem · 0

    IT WAS REPORTED, THE RESECTION SHEATH CERAMIC TIP WAS DEBONDING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069517 INNER SHEATH, FOR 26 FR. OUTER SHEATH RESECTION SHEATH HIH OLYMPUS WINTER & IBE GMBH A22040A 21102 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OTV-S300 (VISERA ELITE II VIDEO SYSTEM CENTER).