BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT SOURCE, LED 3000

    MDR report key: 8155313 · Received December 12, 2018

    Report

    Report Number
    3003604053-2018-00193
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Report Date
    January 3, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWC
    PMA / PMN Number
    K093792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE REASSESSMENT DETERMINED THAT THE ISSUE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. DUE TO THE INCIDENT DID NOT OCCURRED DURING THE PROCEDURE. THIS REPORT WAS MADE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAD NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT SOURCE BOARD IS OUT; IT HAS NO LIGHT. INCIDENT OCCURRED BEFORE THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT SOURCE BOARD IS OUT; IT HAS NO LIGHT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997581 LIGHT SOURCE, LED 3000 CAMERA, TELEVISION, SURGICAL, WITH AUDIO FWC SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1