BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SONOSURG SCISSORS 5 MM O.D., HF SERIES

    MDR report key: 2221383 · Received August 12, 2011

    Report

    Report Number
    8010047-2011-00186
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    April 27, 2011
    Report Date
    July 14, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE PT HAD BEEN DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 AND WAS REPORTEDLY DOING FINE. THE BROKEN DEVICE REPORTEDLY DID NOT HAVE ANY SHARP EDGES AND WAS 0.8MM IN DIAMETER AND 0.7MM IN LENGTH. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR EVAL. THE EVAL FOUND ONE OF THE PINS ON THE GRASPING PORTION OF THE DEVICE WAS BROKEN AND THE OTHER PIN WAS BENT. THE OEM CONCLUDED THAT THE DISTAL END OF THE SUBJECT DEVICE BROKE DUE TO EXCESSIVE FORCE APPLIED TO THE GRASPING PORTION OF THE DEVICE IN THE ATTEMPT TO OPENING IT FURTHER. THE USER FACILITY REPORTED THAT THE DEVICE HAD BEEN USED EXTENSIVELY. THE MFG HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A RESECTION OF THE THYMUS FOR THYMOMA PROCEDURE, THE DISTAL END OF THE SUBJECT DEVICE WAS NOTED BROKEN ON THE ENDOSCOPIC IMAGE. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A DIFFERENT, UNIDENTIFIED DEVICE. A CHEST X-RAY AND CT SCAN WERE SAID TO HAVE BEEN PERFORMED, BUT COULD NOT LOCATE THE DEVICE. THE USER FACILITY HAD REPORTEDLY DETERMINED THAT THE BROKEN PORTION OF THE DEVICE HAD FALLEN OFF OUTSIDE OF THE PT'S BODY. THERE WAS NO PT HARM REPORTED. THE PT WAS REPORTEDLY DISCHARGED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SONOSURG SCISSORS 5 MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORP. T3105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR