BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOGURG SCISSORS 5 MM O.D., NON HF SERIES

    MDR report key: 3961062 · Received May 26, 2014

    Report

    Report Number
    8010047-2014-00275
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    February 18, 2014
    Report Date
    May 2, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. THIS WILL BE SUPPLEMENTED IF DEVICE EVALUATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING SLEEVE GASTRECTOMY, THE PROBE OF THE SUBJECT DEVICE BROKE AND THE FRAGMENT FELL OFF INTO THE PATIENT'S ABDOMINAL CAVITY. THE FRAGMENT WAS RETRIEVE IMMEDIATELY AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE USED 3 TIMES. THERE WAS NO REPORT OF PATIENT'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310055 SONOGURG SCISSORS 5 MM O.D., NON HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3775 NA

    Patients

    Seq Age Sex Outcome Treatment
    1