BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION SHEATH

    MDR report key: 3170658 · Received March 22, 2013

    Report

    Report Number
    9610773-2013-00036
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 6, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE TIP BROKE OFF INSIDE THE PATIENT'S BLADDER DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE WHERE THE TIP WAS RETRIEVED WITH AN UNSPECIFIED GRASPER. THE INTENDED PROCEDURE REPORTEDLY WAS ABORTED AND HAD NOT YET BEEN RESCHEDULED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT. THE INSULATION BEAK WAS CRACKED AND BROKE OFF FROM THE METAL SHEATH AT THE DISTAL END. THERE WERE NO SIGNS OF INDENTATION OR DAMAGES NOTED ON THE METAL SHEATH. THE INSULATION BEAK WAS AN OLDER VERSION. THE REFERENCED DEVICE HAD BEEN FORWARDED TO THE OEM FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE REFERENCED DEVICE FAILED AFTER SEVERAL USES. THE TIP FELL OFF DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121083 OLYMPUS RESECTION SHEATH RESECTION SHEATH FED OLYMPUS WINTER & IBE GMBH A22041A 125W

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR OLYMPUS UES-40 GENERATOR WITH UNK SERIAL #