BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM

    MDR report key: 7105395 · Received December 11, 2017

    Report

    Report Number
    2523190-2017-00152
    Event Type
    Injury
    Date Received
    December 11, 2017
    Report Date
    December 6, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FST
    PMA / PMN Number
    K864380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE ULTRALITE HEADLIGHT SYSTEM WAS RETURNED IN USED CONDITION WITH A REPLACEMENT CABLE ATTACHED. THE REPLACEMENT CABLE'S "Y" JUNCTION HAD BECOME SEPARATED ON ONE SIDE. THE HEADLIGHT WAS FOUND TO SHOW CUSTOMER LABELING AND WEAR. THE FIBER OPTIC CABLE WAS DISCOLORED, WORN, AND DAMAGED. EVALUATION OF THE DEVICE SHOWED NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY. A REVIEW OF MANUFACTURING RECORDS FOUND NO NONCONFORMANCES. CORRECTED DATA: THE INITIAL REPORTED INDICATED THE HEADLIGHT CABLE WAS LOOSE AND NOT SAFE FOR USE. THE INABILITY TO USE THE DEVICE RESULTED IN A HOUR DELAY IN A PATIENT PROCEDURE. (B)(4).

    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

    THE HEADLIGHT CABLE IS LOOSE AND IT IS NOT SAFE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884057 UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM CABLES FST INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other