BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, VISIONPRO SYNK 26" WIRELESS LED DISPLAY

    MDR report key: 6327083 · Received February 13, 2017

    Report

    Report Number
    0002936485-2017-00163
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 13, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K081995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: FIRST TIME USED BY THE ACCOUNT IMAGE WORKED FOR FIRST 10 MIN OF PROCEDURE- THEN IMAGE WENT CRAZY- PIC . THE PROBABLE ROOT CAUSE/S COULD BE MAINBOARD AND WIRELESS RECEIVER BOARD FAILURE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE WAS LOST DURING PROCEDURE. A BACKUP MONITOR WAS OBTAINED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110132 PKG, VISIONPRO SYNK 26" WIRELESS LED DISPLAY LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1