BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA COUPLER AC HD 5:4

    MDR report key: 20166377 · Received September 8, 2024

    Report

    Report Number
    3003604053-2024-00048
    Event Type
    Malfunction
    Date Received
    September 8, 2024
    Date of Event
    August 15, 2024
    Report Date
    September 8, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FEI
    UDI-DI
    00885554024593
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). D4, SERIAL NUMBER.: THE SERIAL NUMBER OF THE COUPLER IS: (B)(6), AND THE SERIAL NUMBER OF THE CAMERA HEAD IS STILL UNKNOWN. HOWEVER, IT IS UNKNOWN WHICH OF BOTH DEVICES CONTRIBUTED TO THE SURGICAL DELAY. H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE COUPLER WAS STUCK WITH THE CAMERA HEAD. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562377 CAMERA COUPLER AC HD 5:4 INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE FEI SMITH & NEPHEW, INC. 00885554024593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown