BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SCISSORS

    MDR report key: 3040566 · Received March 12, 2013

    Report

    Report Number
    9610773-2013-00028
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 21, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN MORE DETAILED INFO REGARDING THE REPORTED EVENT BUT WITH NO RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE DETERMINED. IF ADD'L INFO IS RECEIVED AT A LATER TIME, THEN A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC HYSTEROSCOPY THE SCISSOR BROKE, AND THE SCISSOR BLADE WAS NOTED TO BE MISSING AFTER THE PROCEDURE. THE PT REPORTEDLY LEFT AND THE MISSING SCISSOR BLADE WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104228 OLYMPUS SCISSORS SCISSORS KNS OLYMPUS WINTER & IBE GMBH A4826 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK