BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 353826 · Received September 28, 2001

    Report

    Report Number
    1317214-2001-00040
    Event Type
    Malfunction
    Date Received
    September 28, 2001
    Date of Event
    August 23, 2001
    Report Date
    August 31, 2001
    Manufacturer
    CONMED CORP.
    Product Code
    HBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A LAPAROSCOPIC CHOLECYSTECTOMY FELL FROM THE JAWS OF THE CLIP APPLIER INTO THE SURGICAL FIELD. IT WAS RETRIEVED. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS NOT ALTERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44147 REFLEX ELC ENDOSCOPIC CLIP APPLIER HBT CONMED CORP. NA 0106131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other