BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 20626981 · Received November 7, 2024

    Report

    Report Number
    9610773-2024-02658
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 17, 2024
    Report Date
    June 11, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. CORRECTED FIELDS: D8 THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE CERAMIC TIP WAS FROM A THIRD PARTY REPAIR. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THIRD PARTY REPAIR SO THAT DEFINED BIOCOMPATIBLE CHARACTERISTICS ARE NO LONGER GUARANTEED (EXAMPLE: IMPROPER ADHESIVES USED; IMPROPER MATERIALS USED) AND DEFINED MECHANICAL CHARACTERISTICS ARE NO LONGER GUARANTEED (MELTING OF IMPROPER INSULATION MATERIAL INSTEAD OF CERAMIC). A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. G4: PMA/510(K) NUMBER: (K931994/K931995); ADDED HERE DUE TO CHARACTER LIMITATION IN RESPECTIVE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE OUTER SHEATH EXHIBITED A FAULTY CERAMIC TIP. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998850 INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A HIH OLYMPUS WINTER & IBE GMBH A22040A 131W-0067 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown