BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUPLER, ZOOM, HD, C-MOUNT

    MDR report key: 8611494 · Received May 15, 2019

    Report

    Report Number
    1220246-2019-01097
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    FEI
    UDI-DI
    04056702002268
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION CONFIRMED THE DAMAGE TO THE DEVICE. CONSEQUENTLY, THE DEVICE WAS NOT ABLE TO ADEQUATELY SECURE THE TEST SCOPE. THE CAUSE WAS ATTRIBUTED TO MISHANDLING/MISUSE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION OF THE C-MOUNT ZOOM COUPLER, AR-3210-0006, IT HAD CLEAR VISIBLE DAMAGE AND THE COUPLER DID NOT SCREW INTO THE SCOPE PROPERLY. THE BROKEN COUPLER WAS TAGGED FOR ISOLATION AND, IN THIS INSTANCE, IT WAS NOT USED. UNFORTUNATELY IT WAS PUT BACK INTO SERVICE AND THE NEXT SURGEON OPERATED USING THE DAMAGED COUPLER. DURING A CYSTOSCOPY PROCEDURE, THE C-MOUNT ZOOM COUPLER, AR-3210-0006, WAS USED AND PIERCED THE PATIENT'S BLADDER WALL LEADING TO AN OVERNIGHT STAY IN THE HOSPITAL TO MONITOR PATIENTS CONDITION. NO FURTHER DETAILS PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 5/1/2019: THE ZOOM OPTICAL C-MOUNT COUPLER WAS NOT ABLE TO SCREW IN PROPERLY TO THE C-MOUNT CAMERA. DURING THE OPERATION THE COUPLER DISENGAGED FROM THE CAMERA AND THE SCOPE INADVERTENTLY PIERCED THE PATIENTS BLADDER WALL. THE SCOPE USED WAS NOT AN ARTHREX SCOPE. AT THIS STAGE THE PRIMARY OBJECTIVE OF THE CYSTOSCOPY WAS ALREADY COMPLETED AND THE SURGEON WAS HAPPY TO END THE CASE. THE PATIENT WAS ADMITTED OVERNIGHT POST SURGERY FOR OBSERVATION PURPOSES. NO SUBSEQUENT ISSUES WERE REPORTED AND THEY WHERE ALLOWED TO GO HOME THE FOLLOWING MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406255 COUPLER, ZOOM, HD, C-MOUNT INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE FEI ARTHREX, INC. COUPLER, ZOOM, HD, C-MOUNT 10262343 04056702002268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other