BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 10077708 · Received May 21, 2020

    Report

    Report Number
    1418479-2019-00024
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Report Date
    October 1, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207011874
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT SUCTION PUMP WITH THE SERIAL NUMBER (B)(4) ORIGINATES FROM BATCH 1323598 AND WAS CREATED ON 09/23/3016 IN A LOT SIZE OF 6 PIECES. NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE INSPECTION REVEALED A THERMALLY DEFORMED DOUBLE SILENCER (74011060). THE DOUBLE SILENCER IS SUPPLIED BY METZGER TECHNIK. DUE TO THE CONTINUOUS OPERATION OF THE PUMP AND OVERHEATING AT THE OUTLET, THE DOUBLE SILENCER DOES NOT SWITCH OFF AND IS THERMALLY OVERHEATED AND DEFORMED. THE CAUSE CAN BE TRACED BACK TO A LEAK DURING VACUUM BUILD-UP DURING APPLICATION. POSSIBLE CAUSES CAN BE THE HOSE SET, BACTERIA FILTER OR FLOAT VALVE. THERE IS NO DIRECT PATIENT RISK FROM THE EVALUATION OF THE AVAILABLE INFORMATION. THE USER IS WARNED BY THE LOUD OPERATING NOISES AND THE ERROR MESSAGE "VACUUM BUILD-UP ERROR" THAT THERE IS A LEAK IN THE STRUCTURE DURING THE VISUAL FUNCTION CHECK BEFORE THE APPLICATION. THE GA-A252 CONTAINS SUFFICIENT INSTRUCTIONS FOR VISUAL AND FUNCTIONAL CHECKS AS WELL AS FOR PROPER USE. IN THE RISK ASSESSMENT E3-1, POSSIBLE RISKS TO THE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK. IN ORDER TO PREVENT POSSIBLE EQUIPMENT FAILURE, A SECOND, EQUIVALENT PUMP SHOULD BE AVAILABLE. NO SYSTEMATIC DEFICIENCIES CAN BE DERIVED FROM THE INSPECTION OF THE PUMP FROM A MANUFACTURING OR DESIGN POINT OF VIEW. BASED ON THIS RESULT NO CONSTRUCTION/USER ERRORS ARE POSSIBLE. THIS CASE IS CONSIDERED CLOSED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON OCTOBER 01, 2019, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED THE FOLLOWING INFORMATION: DURING MORCELLATION THE UNIT STOPPED WORKING. THERE WAS A TRIANGLE ERROR CODE AND THE ALARM WENT OFF. THERE WAS NO PATIENT INJURY AND THE CASE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541556 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other