BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LIGHT SOURCE

    MDR report key: 6417335 · Received March 20, 2017

    Report

    Report Number
    9611102-2017-00004
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 20, 2017
    Manufacturer
    RICHARD WOLF GERMANY (GMBH)
    Product Code
    GCT
    UDI-DI
    04055207012901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE HAS NOT BEEN RETURNED BUT IS CURRENTLY IN TRANSIT TO MANUFACTURER. INVESTIGATION/EVALUATION OF DEVICE NOT YET INITIATED. REVIEW OF PRODUCTION RECORDS CURRENTLY IN PROCESS. (B)(4) CONSIDERS THIS REPORT OPEN, FOLLOW-UP REPORT TO BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1. THE FOLLOWING SECTIONS UPDATED/ADDED: PRODUCT PROBLEM, SUSPECT DEVICE, ALL MANUFACTURERS, DEVICE MANUFACTURERS. THE LIGHT PROJECTOR WAS TESTED IN THE RESPONSIBLE DEPARTMENT. NO MALFUNCTIONS WERE DETECTED. THE DEVICE LOGFILE STORES THE ERROR MESSAGE AVR-P1 IN COMBINATION WITH XXX-XXX-407. ACCORDING TO GA-A264 CHAPTER 5.10.6 THIS MEANS AN "ELECTRONIC FAULT" ON THE FUNCTION BOARD WITH MEDIUM PRIORITY (YELLOW). THE USER HAS TO NOTIFY THE CUSTOMER SERVICE. ALSO STORED IN THE LOGFILE IS THE ERROR ENTRY XXX-XXX-040 AFTER APPROX. 300 OUT OF 624 OPERATING HOURS. THIS ERROR STATES (GA CHAPTER 5.10.5 ERROR LOW (TURQUOISE)) THAT THE INITIALIZATION HAS FAILED. THE USER IS REQUESTED TO PERFORM A DEVICE RESTART. IF THE ERROR OCCURS AGAIN, THE CUSTOMER SERVICE MUST ALSO BE INFORMED. ACCORDING TO LOGFILE, THIS ERROR OCCURRED ONLY ONCE. DUE TO THE ERROR DESCRIPTION OF THE CUSTOMER IS TO ASSUME A SPORADIC ERROR, IT IS STILL QUESTIONABLE WHICH MALFUNCTION / COMPONENT ON THE E-BOARD (FUNKTIONSBOARD) IS RESPONSIBLE, ESPECIALLY SINCE THE ERROR DURING THE TEST IN HOUSE DID NOT OCCUR. THE E-BOARD IS REPLACED AS A PRECAUTION. THE 5142002 LIGHT SOURCE X 300 300W WITH THE (B)(4) WAS POSTED ON 19FEB2014 ON THE SALES WAREHOUSE. THE PRODUCTION ORDER (B)(4) CONSISTS OF (B)(4) PIECES. THE 5142002 LIGHT SOURCE X 300 300W WITH THE (B)(4) ON 15APR2014 WITH DELIVERY NOTE NO. (B)(4) WAS DELIVERED TO THE COMPANY (B)(6). LAMP OPERATING HOURS: 412H, LAMP CURRENT: 412H, RESET: 0, TOTAL DEVICE HOURS: 722H48MIN, DEVICE ON / OFF: 643. THE USER IS INFORMED ACCORDING TO THE OPERATING INSTRUCTIONS FOR THE LIGHT PROJECTOR HIGHLIGHT X300 51420X2, GA-A 264 / DE / 2014-02 (B)(4) / PDG 13-6759 THAT IN CASE OF A POSSIBLE DEVICE FAILURE, AN EQUIVALENT LIGHT PROJECTOR MUST BE AVAILABLE FOR THERAPEUTIC USE. POSSIBLE HAZARDS WERE TAKEN INTO ACCOUNT IN THE RISK ASSESSMENT E4-1 R01 (XENON LIGHT SOURCES) WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. THIS RATING IS STILL VALID CONSIDERING THE CURRENT CASE. RICHARD WOLF (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) SUBMITTING REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    RICHARD WOLF (B)(4) WAS NOTIFIED THAT DURING A PROCEDURE THE DEVICE IN QUESTION STOPPED AND AN ERROR MESSAGE DISPLAYED ON SCREEN. A BACK UP DEVICE WAS NOT READILY AVAILABLE AND PROCEDURE STOPPED AND RESCHEDULED. DELAY IN PROCEDURE MAY HAVE PLACED PATIENT AT RISK.

    Description of Event or Problem · 1

    FOLLOW UP #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199433 ENDOSCOPIC LIGHT SOURCE LIGHT SOURCE GCT RICHARD WOLF GERMANY (GMBH) 5142.002 04055207012901

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR