BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEA,JAW,GRSPR.S/A ATRMTC

    MDR report key: 352209 · Received September 14, 2001

    Report

    Report Number
    1219602-2001-00102
    Event Type
    Malfunction
    Date Received
    September 14, 2001
    Date of Event
    August 1, 2001
    Report Date
    September 14, 2001
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVIS
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACTUATOR PIVOT WAS BROKEN FREE FROM THE FRONT END ASSEMBLY OF THE DEVICE. THE FRONT ACTUATOR HAS BEEN REPORTED AS MISSING BY THE SALES REP. AND IS THEREFORE CONSIDERED TO BE INSIDE THE PATIENT. THERE WAS NO PROCEDURAL DELAY OR PATIENT INJURY REPORTED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41936 FEA,JAW,GRSPR.S/A ATRMTC * KOG SMITH & NEPHEW, INC., ENDOSCOPY DIVIS NA 401524

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN