BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17187822 · Received June 22, 2023

    Report

    Report Number
    9610773-2023-01718
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 18, 2023
    Report Date
    November 7, 2023
    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

    THIS IS A SUPPLEMENTAL REPORT TO CORRECT THE INITIAL MDR. THE INITIAL MEDWATCH REPORTED THAT THE RESECTION SHEATH HAD A BROKEN CERAMIC TIP; HOWEVER; THIS WAS INCORRECTLY REPORTED. THE CUSTOMER REPORTED THE PLASTIC PART WAS BROKEN, THERE WERE NO ISSUES WITH THE CERAMIC TIP. PER THE LEGAL MANUFACTURER, THIS ISSUE OF THE BROKEN PLASTIC PART IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K931995.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A RESECTION SHEATH HAD A BROKEN CERAMIC TIP. THE REPORTED PROBLEM WAS FOUND DURING REPROCESSING AFTER PROCEDURE. THE INTENDED PROCEDURE WAS PLASMA SURGERY. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002314 RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS SURG, NON-EN HIH OLYMPUS WINTER & IBE GMBH A42011A 189W-0017 04042761023658

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown