BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19974490 · Received August 13, 2024

    Report

    Report Number
    9610773-2024-01953
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    August 4, 2024
    Report Date
    August 20, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761023658
    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. G4/PREMARKET IDENTIFICATION: PMA/510(K) NUMBER: (K931994/K931995); ADDED HERE DUE TO CHARACTER LIMITATION IN RESPECTIVE FIELD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF DEVICE HISTORY RECORD AND HISTORICAL COMPLAINTS ANALYSIS WAS CONDUCTED AND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF DAMAGE WAS THERMALLY AND MECHANICALLY INDUCED BASED ON THE DAMAGE PATTERN. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE RESECTION SHEATH EXHIBITED A DAMAGED CERAMIC TIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PATIENT WAS NOT UNDER ANY ANESTHESIA. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620182 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS RESECTION SHEATH HIH OLYMPUS WINTER & IBE GMBH A42011A 108W-0004 04042761023658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown