BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTF-Y0032

    MDR report key: 8427827 · Received March 18, 2019

    Report

    Report Number
    8010047-2019-01307
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE DEVICE AND CONFIRMED NO IRREGULARITY THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A LAPAROSCOPIC SURGERY, A FRAGMENT FELL OFF FROM THE BENDING SECTION OF THE SUBJECT DEVICE WITHIN THE PATIENT. THE FRAGMENT WAS RETRIEVED USING A GRASPING FORCEPS AND THE PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. AFTER WITHDRAWING OF THE SUBJECT DEVICE FROM THE PATIENT, THE USER FACILITY FOUND THAT A PART OF THE BENDING SECTION ADHESIVE CRACKED AND THE FRAGMENT WAS THE PART OF THE ADHESIVE. THE SUBJECT DEVICE HAD BEEN STERILIZED BY AUTOCLAVE. THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222375 LTF-Y0032 UNKNOWN GCJ OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN 260K010

    Patients

    Seq Age Sex Outcome Treatment
    1