BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 10CM INLINE GRIP

    MDR report key: 3823106 · Received January 20, 2014

    Report

    Report Number
    8010047-2014-00014
    Event Type
    Malfunction
    Date Received
    January 20, 2014
    Date of Event
    July 19, 2013
    Report Date
    July 22, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION. THE MANUFACTURING RECORD OF THE AFFECTED LOT NUMBER WAS REVIEWED WITH NO IRREGULARITIES. OMSC COULD NOT DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED. HOWEVER, BASED ON THE SIMILAR EVENT, THE PTFE PAD IS MOST LIKELY TO COME AWAY FROM THE GRASPING SECTION IS CLOSED WITHOUT ANY TISSUE. IMPROPER HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORT EVENT. THE ABOVE HANDLING HAS ALREADY BEEN RESTRICTED ON THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING UNCERTAIN SURGERY, THE PTFE PAD HAD COME AWAY FROM THE GRASPING SECTION OF THE SUBJECT DEVICE. THEY SWAPPED IN ANOTHER SIMILAR DEVICE IMMEDIATELY AND CONTINUED WITH THE PROCEDURE SUCCESSFULLY. FURTHER INFO COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46645 THUNDERBEAT 5MM 10CM INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0510IC 27K

    Patients

    Seq Age Sex Outcome Treatment
    1