BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS RESECTION SHEATH

    MDR report key: 1983694 · Received February 3, 2011

    Report

    Report Number
    9610773-2011-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO AND WAS INFORMED OF THE FOLLOWING INFO: THE DEVICE WAS REPORTED TO HAVE BEEN USED IN THE PROCEDURE FOR ABOUT FIVE TO TEN MINUTES WHEN THE CERAMIC TIP OF THE RESECTION SHEATH REPORTEDLY BROKE AND FELL INTO THE PT. THE BROKEN CERAMIC TIP WAS IMMEDIATELY RETRIEVED USING GRASPER FORCEPS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THE STAFF REPORTED THAT AN X-RAY WAS PERFORMED SUBSEQUENT TO THE REPORTED EVENT AND REVEALED NO EVIDENCE OF DEVICE FRAGMENTS INSIDE THE PT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE CERAMIC BEAK ON THE DISTAL END OF THE UNIT WAS HEAVILY DAMAGED. A PORTION OF THE CERAMIC BEAK WAS BROKEN OFF AND NOT RETURNED, AND THERE WAS EVIDENCE OF THERMAL DAMAGE AT THE EDGE OF A PORTION OF THE FRACTURE JUNCTION. BASED UPON THE FINDINGS OF THIS INVESTIGATION, IT APPEARS THE CAUSE OF THIS PHENOMENON WAS RELATED TO PHYSICAL DAMAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) IN AN ABUNDANCE OF CAUTION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A TRANSURETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE A PORTION OF THE CERAMIC TIP OF A RESECTION SHEATH BROKE OFF AND FELL INSIDE THE PT. THE BROKEN PIECE WAS RETRIEVED USING AN UNK MODEL OF GRASPER FORCEPS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION SHEATH RESECTION SHEATH FAS OLYMPUS WINTER & IBE GMBH A22042A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR