BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)

    MDR report key: 8567395 · Received April 30, 2019

    Report

    Report Number
    0002936485-2019-00170
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    March 1, 2019
    Report Date
    August 22, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OWN
    UDI-DI
    07613327174328
    PMA / PMN Number
    K142310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. ALLEGED FAILURE: CAMERA MALFUNCTIONED DURING THE PROCEDURE CAUSING ODD IMAGES TO APPEAR ON THE SCREEN. CONFIRMED FAILURE: DIGITAL BOARD FAILURE. PROBABLE ROOT CAUSE: - CABLES - CONNECTORS - DIGITAL BOARD - MAIN BOARD - TRANSITION BOARD - FIBER BOARD - INTERMITTENCE BETWEEN TRANSITION BOARD AND CH CONNECTOR - SOFTWARE - CAMERA HEAD - INTERMITTENCE WHILE USING RF DEVICES - CONNECTED MONITORS - LEAKING - USE ERROR - POOR GROUNDING - ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE MANUFACTURING/ SERVICE NONCONFORMITY. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ODD IMAGES APPEARED ON THE SCREEN AND LED TO A LOSS OF IMAGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ODD IMAGES APPEARED ON THE SCREEN AND LED TO A LOSS OF IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360776 PKG, 1588 AIM CAMERA CONTROL UNIT (CCU) CONFOCAL OPTICAL IMAGING OWN STRYKER ENDOSCOPY-SAN JOSE 07613327174328

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR