BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 478430 · Received August 12, 2003

    Report

    Report Number
    1317214-2003-00041
    Event Type
    Malfunction
    Date Received
    August 12, 2003
    Date of Event
    July 25, 2003
    Report Date
    July 25, 2003
    Manufacturer
    CONMED CORP.
    Product Code
    HBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A SURGICAL PROCEDURE, THE JAWS OF THE CLIP APPLIER WOULD NOT CLOSE AND A CLIP WAS DROPPED INTO THE SURGICAL FIELD. THE CLIP WAS NOT RETRIEVED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ELC ENDOSCOPIC CLIP APPLIER HBT CONMED CORP. NA 0305293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other