BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENS 4K A/C CAMERA HEAD

    MDR report key: 11143662 · Received January 9, 2021

    Report

    Report Number
    1643264-2021-00092
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 8, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    UDI-DI
    00885556720790
    PMA / PMN Number
    K191177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT IDENTIFY ANY ISSUES. FUNCTIONAL EVALUATION REVEALED THAT THERE WAS LOSS OF IMAGE WHEN THE CONNECTOR IS MOVED. THE COMPLAINT HAS BEEN CONFIRMED AND THE ROOT CAUSE HAS BEEN ASSOCIATED WITH AN ELECTRICAL COMPONENT FAILURE. FACTORS, UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT, INCLUDE A DAMAGED CONNECTOR. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE LOT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS 4K A/C CAMERA HEAD PRESENTED A BLACK SCREEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40251 LENS 4K A/C CAMERA HEAD LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SMITH & NEPHEW, INC. 72205058 00885556720790

    Patients

    Seq Age Sex Outcome Treatment
    1