BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER, ZOOM, HD, C-MOUNT

    MDR report key: 14744798 · Received June 20, 2022

    Report

    Report Number
    1220246-2022-05121
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 27, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    FEI
    UDI-DI
    04056702002268
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. (1) UNPACKAGED AR-3210-0006 ZOOM COUPLER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED AN INTERNAL LENS WAS DETACHED AND REMAINED LOOSE INSIDE THE COUPLER. THE DEVICE ALSO PRODUCED A RATTLING SOUND WHEN SHOOK. FUNCTIONAL TESTING WITH A CAMERA HEAD REVEALED THE IMAGE WAS NOT CENTERED ON THE DISPLAY, AND THERE WERE ISSUES WITH ZOOMING AND FOCUSING. WITHOUT ADDITIONAL INFORMATION, A CAUSE CANNOT BE DETERMINED. HOWEVER, A PROBABLE CAUSE COULD BE ATTRIBUTED TO IMPACT WITH A HARD SURFACE, SUCH AS DROPPING THE DEVICE ON THE FLOOR.

    Description of Event or Problem · 0

    ON 05/31/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0006 COUPLERS ARE EXPERIENCING AN ISSUE WITH ZOOMING, AND AUTO FOCUSING. THE IMAGE IS NOT CENTERED ON THE TOWER. THIS OCCURRED ON (B)(6) 2022 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CASE HAD TO BE ABORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 06/07/2022: THE PATIENT WAS SEDATED WITH TRANSABDOMINAL PREPERITONEAL BLOCK (TAPP). THERE WAS NO SKIN INCISION MADE, AN THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262401 COUPLER, ZOOM, HD, C-MOUNT INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE FEI ARTHREX, INC. COUPLER, ZOOM, HD, C-MOUNT 10636354 04056702002268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other