BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM

    MDR report key: 6121017 · Received November 22, 2016

    Report

    Report Number
    2523190-2016-00197
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Report Date
    November 8, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FST
    PMA / PMN Number
    K071218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/30/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THERE WAS A UL PRO FUSED CABLE RETURNED BECAUSE THE END FITTING WAS BURNT BY THE MLX LIGHT SOURCE. THERE IS NO DEFICIENCY IDENTIFIED WITH THE CABLE. THE LIGHT SOURCE CAUSE THE DAMAGE TO THE CABLE. WITHOUT THE LIGHT SOURCE IT CANNOT BE DETERMINED WHY LIGHT SOURCE GENERATED ENOUGH HEAT TO DAMAGE THE CABLE. THE COMPLAINT CAN BE CONFIRMED, DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER / MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. REPAIR HISTORY: N/A. CONCLUSION: THERE IS NO DEFICIENCY IDENTIFIED WITH THE CABLE. THE ROOT CAUSE CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS CABLE END-FITTING BURNED BY MLX. ON (B)(6) 2016 CUSTOMER REPORTS ISSUE WAS FOUND DURING AN OPEN GALLBLADDER, ABOUT HALFWAY THROUGH THE PROCEDURE, NO HARM TO PATIENT. NO FURTHER INFORMATION AVAILABLE. #2 OF 2 RELATED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772143 UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM CABLES FST INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1