BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY CONSOLE

    MDR report key: 8224686 · Received January 7, 2019

    Report

    Report Number
    0002936485-2019-00009
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    December 17, 2018
    Report Date
    April 26, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LLZ
    UDI-DI
    00869958000117
    PMA / PMN Number
    K130929
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RECEIVED AT STRYKER ENDOSCOPY AND WAS SHIPPED TO THE LEGAL MANUFACTURER, ZMICRO FOR EVALUATION. THE OEM INVESTIGATION REPORT INDICATES: "ANALYSIS SUMMARY (ATTACH OR REFERENCE ALL RELEVANT INFORMATION.) 1/18/2019: THE REPORTED MALFUNCTION DOES NOT NEED TO BE REPORTED PER MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF SECTION 2.14. UPDATED 2/4/2019: RECEIVED UNIT WITH SCRATCHES ON CHASSIS AND TOP, NO OTHER DAMAGES NOTED. UNABLE TO DUPLICATE REPORTED FAILURE OF UNIT EXHIBITING VIDEO ISSUE. TESTED AND VERIFIED SYSTEM FUNCTIONALITIES. VERIFIED VIDEO SIGNAL ON ALL IN/OUTPUT SOURCES. UNIT REQUIRES SERVICE OBJECT 1804-C1-00101 WHICH CONSISTS OF VARIOUS FIRMWARE APPLICATION UPDATES. UNIT ALSO REQUIRES GROUND SAFETY LABEL AND UPDATED SERIAL LABEL. UPDATED MAIN CONTROLLER BOARD 11-93667.00.001 REV. 50 32-00214 REV. 50 32-00146 REV. 50 32-00138 REV. 55 UPDATED OUTPUT BOARD 11-93670.02.001 REV. 50 32-00215 REV. 50 INSTALLED GROUND SAFETY LABEL (VF ROUTE: 32 VN) REPLACED SERIAL LABEL (VF ROUTE: 32 VN) INITIAL TEST (21-0102TP REV. E 8.3) BURN-IN TEST (21-0102TP REV. 8.7) FINAL TEST (21-0102TP REV. 8.10) UNIT FUNCTIONALITY TESTED IN ACCORDANCE WITH ATP TEST PROCEDURE 21-0102TP REV E, SECTION 8.7 BURN-IN TEST PERFORMED WITH NO FAILURES FOUND. EQUIPMENT USED IN DIAGNOSTIC AND TESTING OF THIS UNIT WAS: DELL PRECISION TOWER 3620 - S/N: (B)(4), CINEREOID PATTERN GENERATOR - S/N: (B)(4), 4K DISPLAY BM230-4K, S/N: (B)(4). THE REPORTED SYMPTOMS AND ISSUE RESOLUTION CORRELATE WITH THE SYMPTOMS THAT WERE INVESTIGATED ON CA0192 AND RESOLVED WITH C1-00099." THE FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMAGE BECAME GRAINY AND HAD TO CONVERT TO OPEN SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE BECAME GRAINY AND HAD TO CONVERT TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15405 CLARITY CONSOLE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ STRYKER ENDOSCOPY-SAN JOSE 00869958000117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other