BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA COVER ADAPTOR FOR STRYKER VISIUM LED

    MDR report key: 7285900 · Received February 21, 2018

    Report

    Report Number
    1836161-2018-00019
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 18, 2018
    Report Date
    January 23, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT INDICATING THAT A CAMERA COVER ADAPTOR WAS LOOSE WHICH HAD POTENTIAL TO FALL INTO STERILE FIELD. THE REPORT CAME FROM AN ASPEN ACCOUNT REPRESENTATIVE. THE ACTUAL DEVICE WAS AVAILABLE FOR EVALUATION AND A LOT NUMBER WAS PROVIDED FOR REVIEW. ANALYSIS RESULT OF THE FINISHED GOOD LOT NUMBER 140736 CONFIRMED THAT NO NON-CONFORMANCE'S WERE NOTED IN THE DHR. THE SAMPLE THAT WAS SENT FOR EVALUATION APPEARED TO BE UNUSED. NO ISSUES OR DEFECTS WERE DISCOVERED WITH THE DEVICE, THEREFORE THE ALLEGED MALFUNCTION COULD NOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED FROM THE COMPANY REPRESENTATIVE, THE ADAPTOR WAS USED ON A STRYKER HD HARDWIRE CAMERA. HOWEVER, THE CURRENT ADAPTOR IS NOT DESIGNED FOR THIS HD HARDWIRE CAMERA. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM AN ASPEN COMPANY REPRESENTATIVE INDICATING THAT A CAMERA COVER ADAPTOR IS LOOSE WHICH HAS POTENTIAL TO FALL INTO STERILE FIELD. THE ITEM WAS IN USE AND NO INJURY/DEATH WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM AN ASPEN COMPANY REPRESENTATIVE INDICATING THAT A CAMERA COVER ADAPTOR IS LOOSE WHICH HAS POTENTIAL TO FALL INTO STERILE FIELD. THE ITEM WAS IN USE AND NO INJURY/DEATH WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130891 CAMERA COVER ADAPTOR FOR STRYKER VISIUM LED CAMERA COVER ADAPTOR FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-9905 140736

    Patients

    Seq Age Sex Outcome Treatment
    1