BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 16746906 · Received April 14, 2023

    Report

    Report Number
    9610773-2023-01044
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Report Date
    April 14, 2023
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510(K): K931995. THE DEVICE WAS RETURNED TO OLYMPUS. DURING THEIR INSPECTION, THE SERVICE DEPARTMENT CONFIRMED THE REPORTED DAMAGE. IT IS LIKELY THAT THE REPORTED DAMAGE WAS MOST PROBABLY INDUCED BY THERMO-MECHANICAL FATIGUE. ADDITIONALLY, THE SERVICE DEPARTMENT FINDS THE YELLOW O-RING TO BE BROKEN. THIS IS PROBABLY DUE TO A LEAK FROM THE SHEATH. THE MOST LIKELY CAUSES ARE: THERMO-MECHANICAL FATIGUE, WEAR AND TEAR, IMPROPER HANDLING (IMPACT, SHOCK). A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A RESECTION SHEATH HAD A BROKEN CERAMIC TIP. THE ISSUE WAS FOUND DURING ESTIMATION OF THE DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806844 RESECTION SHEATH, 24 FR. HYSTEROSCOPE HIH OLYMPUS WINTER & IBE GMBH A22041A 42W-0003 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown