BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH

    MDR report key: 3957254 · Received June 17, 2014

    Report

    Report Number
    2951238-2014-00251
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC BIPOLAR CYSTOSCOPY PROCEDURE, A PART OF THE DEVICE BROKE OFF AND FELL INSIDE THE PATIENT. IT WAS STATED THAT THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. IT IS UNKNOWN IF THE DEVICE FRAGMENT WAS RETRIEVED FROM THE PATIENT; HOWEVER, THE USER FACILITY DID NOT REPORT ANY PATIENT INJURY. OLYMPUS HAS FOLLOWED UP WITH THE USER FACILITY FOR ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355075 RESECTION SHEATH RESECTION SHEATH FJL OLYMPUS WINTER & IBE GMBH A22040A 129W-0106

    Patients

    Seq Age Sex Outcome Treatment
    1