BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA PULSE

    MDR report key: 13593674 · Received February 24, 2022

    Report

    Report Number
    9611102-2022-00008
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 9, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH (DEVICE MANUFACTURER). THE INSTRUMENT HAS NOT YET BEEN SENT FOR EXAMINATION BY THE USER. AS SOON AS THE EXAMINATION IS COMPLETED, RWGMBH WILL SEND A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH CORRECTED AND NEW INFORMATION. THE FOLLOWING FIELDS HAVE NEW/CHANGED INFORMATION. THE RESULTS OF THE DEVICE INVESTIGATION: THE AFFECTED DEVICE HAS BEEN TESTED TWICE BY THE SUPPLIER. BOTH TIMES NO FAULT COULD BE FOUND, SO THE DEVICE WAS SENT BACK TO THE CUSTOMER WITHOUT ANY CHANGES ON JUNE 03, 2022. THE 2286007 LASER SURGERY DEVICE TOWER 70W HAS BEEN IN THE PROGRAM SINCE OCTOBER 05, 2017. THE LASER WITH THE SERIAL NUMBER (B)(6) WAS BOOKED IN STOCK ON MAY 27, 2021 AFTER THE SUPPLIER CONFIRMED THE INSPECTION OF THE LASER SURGICAL UNIT WITH NO ABNORMALITIES, RETURNS OR SPECIAL RELEASES VIA OUTGOING INSPECTION REPORT MOD 7.5.1-1-24 DATED MAY 14, 2021. THIS LASER WAS DELIVERED TO THE CUSTOMER IN SPAIN ON JUNE 11, 2021 WITH DELIVERY NOTE #0081949564. UNTIL NOW, THE AFFECTED DEVICE WITH THE SERIAL NUMBER (B)(6) WAS WITHOUT ANY PROBLEMS AND WAS NOW SENT IN FOR REPAIR FOR THE FIRST TIME. FURTHERMORE, FOR THE 2286007 LASER SURGERY DEVICE TOWER 70W NO SIMILAR INCIDENTS WITH THE ERROR MESSAGE "LOW WATER FLOW (1)" ARE KNOWN SO FAR. THE ELECTRICAL PARAMETERS OF THE LASER SURGICAL UNIT TOWER 70W TYPE 2286007 ARE CHECKED AFTER PRODUCTION AT THE SUPPLIER'S PREMISES AND AT RICHARD WOLF GMBH IN ACCORDANCE WITH PA 01-001-9149 BEFORE BEING SHIPPED TO CUSTOMERS, AND THEY ARE ALSO SUBJECTED TO A FUNCTIONAL TEST. THESE TEST STEPS ENSURE THAT NO PRODUCTS ARE DELIVERED WHICH HAVE NOT MET THEIR SPECIFICATIONS. GENERALLY, THE USER IS INFORMED IN THE CORRESPONDING INSTRUCTIONS FOR USE GA -A 327 / EN / 2021-05 V4.0/ PK20-0363, WHAT TO DO IF THE MENTIONED ERROR MESSAGE APPEARS: [...] 4.6.6 FILL HYDRAULIC SYSTEM: THE WATER SYSTEM CONSISTS OF AN INTERNAL COOLING CIRCUIT WHICH REQUIRES 5 LITERS OF BIDISTILLED / DEIONIZED (I.E. FULLY DESALINATED) WATER. CAUTION! ONLY USE BIDISTILLED OR DEIONIZED WATER. THE FOLLOWING INSTRUCTION SEQUENCE DESCRIBES THE CORRECT PROCEDURE TO FILL THE HYDRAULIC CIRCUIT (REFER TO FIGURE 4.1): - FILL THE WATER SYSTEM WITH 5 LITERS OF BIDISTILLED OR FULLY DEIONIZED WATER. - REMOVE THE PLUG ON THE WATER FILL CONNECTOR (1). FOR THIS PURPOSE, PUSH BACK THE RING ON THE BLEEDING VALVE AND PULL OUT THE SEALING PLUG. - CONNECT THE FILL HOSE WITH FILL BOTTLE TO THE WATER FILL CONNECTOR (1). - OPEN THE COVER FOR BLEEDING THE FILL BOTTLE AND SLOWLY FILL IN WATER. - CLOSE THE WATER FILL CONNECTOR (1) USING THE SEALING PLUG. WHEN THE ERROR MESSAGE "LOW WATER FLOW" IS DISPLAYED, CALL UP THE DIAGNOSE MENU (SEE SECTION 5) TO CHECK THE WATER LEVEL. MENU --> DEVICE PARAMETERS --> SERVICE --> DIAGNOSTICS. - TOP UP WATER UNTIL THE OPTIMUM FILL LEVEL IS REACHED. - SELECT THE H2O PUMP PARAMETER AND TOUCH THE OK BUTTON. - THE LEVEL STATUS (FILL LEVEL) ON THE SCREEN SWITCHES TO "OK". - THE CHILLER STATUS SHOULD SWITCH TO "OK" AND FLOW 1 / FLOW 2 SHOULD SWITCH TO "ON". - IF FLOW 1/FLOW 2 REMAIN "OFF", SWITCH OFF THE H2O PUMP AND THEN SWITCH ON AGAIN. IF LEVEL GOES BACK TO "ERROR", REFILL UNTIL LEVEL TURNS "OK". THEN SWITCH ON THE H2O PUMP ONCE MORE. THE ERROR MESSAGES AS WELL AS THE POSSIBLE CAUSES ARE LISTED IN CHAPTER 8 "TROUBLESHOOTING" OF THIS IFU. POSSIBLE DAMAGE OR FUNCTIONAL IMPAIRMENTS CAN BE DETECTED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE OBSERVED. AT RICHARD WOLF GMBH, THESE PRODUCTS ARE LISTED IN RISK PRODUCT GROUP E12-4, IN WHICH MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO A FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO A PRODUCT THAT CANNOT BE USED ARE CONSIDERED WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. SINCE NO NEW RISKS HAVE ARISEN FROM THE INVESTIGATION OF THE CURRENT COMPLAINT CASE, THE RISK ASSESSMENT REMAINS VALID IN VIEW OF THE FACTS DESCRIBED. DUE TO THE FACT THAT THE ERROR MESSAGE REPORTED BY THE USER IS DESCRIBED IN DETAIL IN THE ASSOCIATED INSTRUCTIONS FOR USE AND NO PROBLEMS COULD BE DETECTED ON THE LASER SURGICAL UNIT, WE ASSUME A USER ERROR DUE TO NON-OBSERVANCE OF THE INSTRUCTIONS FOR USE. RICHARD WOLF GMBH CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RW GMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS SUBMITTING THE REPORT ON BEHALF OF RW GMBH.

    Description of Event or Problem · 0

    ON (B)(6) 2022 RICHARD WOLF GMBH WAS INFORMED ABOUT THE FOLLOWING: BEFORE USE IN PATIENT INTERVENTION IT WAS NOTICED THAT THE LASER WAS NOT OPERATIONAL, BECAUSE AN ERROR "LOW WATER FLOW (1)" APPEARS ON SCREEN. THE PATIENT WAS ALREADY ANAESTHETISED. THE TREATMENT WAS CANCELED AND SCHEDULED FOR ANOTHER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300036 MEGA PULSE LASER SURGERY DEVICE TOWER GEX RICHARD WOLF GMBH 2286007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown