BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA SUCTION PUMP

    MDR report key: 9331225 · Received November 15, 2019

    Report

    Report Number
    9611102-2019-00033
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 15, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS CONTAIN NEW/CHANGED INFORMATION: D10, G7, H2, H3, H6, H10. THE PUMP WAS INVESTIGATED BY RICHARD WOLF IN FRANCE. THE EVALUATION DETERMINED THAT THE PUMP HAD NO FUNCTIONAL DEFECTS. THE SUCTION PUMP PIRANHA 2208 IS MAINLY USED FOR FRAGMENTATION AND ASPIRATION OF ENUCLEATED PROSTATE TISSUE. IT IS USED EXCLUSIVELY IN COMBINATION WITH THE POWER CONTROL 2303 AND THE POWER-STICK M4 DURING MORCELLATION AND HAS NO DIRECT PATIENT CONTACT. PIRANHA 2208 PUMP AND POWER CONTROL 2303 ARE CONNECTED BY A CONTROL CABLE. DETAILS ARE DESCRIBED IN THE INSTRUCTIONS FOR USE GA-A252. THE PIRANHA OR SUCTION MODE CAN ONLY BE ACTIVATED USING THE FOOTSWITCH IN "READY FOR OPERATION" MODE. THE FOOTSWITCH IS CONNECTED TO THE PIRANHA SUCTION PUMP ON THE FRONT OF THE UNIT. THE INVESTIGATION OF THE FOOTSWITCH 2030108 (B)(6) HAS SHOWN THAT SEVERAL WIRES IN THE CONNECTOR ON THE DEVICE SIDE WERE VERY STRONGLY TWISTED IN ONE DIRECTION. A BREAK HAS OCCURRED AT THE SOLDER JOINT OF A CABLE STRAND. THIS RESULTED IN THE DEFECT DESCRIBED BY THE CUSTOMER THAT THE MORCELLATOR COULD NO LONGER BE ACTIVATED, BUT SUCTION WAS POSSIBLE. THE CABLE SHEATH WAS FIXED WITH A SCREW DURING THE ASSEMBLY OF THE PLUG SO THAT ON THE ONE HAND THE CABLE CANNOT TWIST, AND ON THE OTHER HAND TENSILE LOADS ON THE CABLE CAN BE ABSORBED. THE PRESSURE POINTS OF THE SCREW WERE CLEARLY VISIBLE ON THE CABLE SHEATH. BASED ON THE AVAILABLE INFORMATION, WE CONCLUDE THAT THERE WAS A HANDLING ERROR IN THIS CASE. IN ORDER TO DETECT DAMAGE TO THE PRODUCT AT AN EARLY STAGE, CHECKS MUST BE CARRIED OUT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. 4 CHECKS IMPORTANT! RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH ANY LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. THE USER IS CLEARLY INFORMED IN THE INSTRUCTIONS FOR USE THAT AN EQUIVALENT REPLACEMENT MUST BE AVAILABLE FOR THERAPEUTIC USE DUE TO POSSIBLE FAILURES. A SEPARATE SUBCHAPTER IS DEVOTED TO CONNECTING THE FOOTSWITCH. 3.1.5 FOOTSWITCH CONNECTION PLACE THE FOOTSWITCH PLUG AGAINST THE SOCKET ON THE DEVICE (SOCKET FOR FOOTSWITCH) AND TURN UNTIL THE CODING LUG ENGAGES IN THE RECESS OF THE SOCKET. THE PLUG CAN THEN BE INSERTED EASILY WITHOUT FORCING IT. THE FOOT SWITCH WAS PRODUCED IN DECEMBER 2015 AND WAS DELIVERED TO RICHARD WOLF FRANCE ON 05.02.2016 TOGETHER WITH THE 2208001 PIRANHA PUMP (B)(6) FOR THE CENTRE HOSPITALIER DE TOULOUSE. NO REPAIRS HAVE YET BEEN CARRIED OUT ON THE FOOT SWITCH BY RICHARD WOLF. THE CUSTOMER'S 2208001 PIRANHA PUMP (B)(6) AND 2303.001 MOTOR CONTROL UNIT (B)(6) WERE REPAIRED IN MARCH AND JUNE 2017. THE TWO REPAIRS ARE NOT RELATED TO THE CURRENT DEFECT. THE DEFECT FOUND ON THE FOOTSWITCH CONNECTOR DOES NOT DESCRIBE A GENERAL PRODUCT PROBLEM INVOLVING NON-CONFORMITY, NEGATIVE TREND OR PREVIOUSLY UNKNOWN HAZARD. A SYSTEMATIC PROBLEM IS NOT RECOGNIZABLE. WARNINGS AND CHECKS ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. NO FURTHER INVESTIGATION OR ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DEVICE IS ON-GOING. THE DEVICE IS IN THE PROCESS OF BEING RETURNED BY RICHARD WOLF (B)(4) TO RICHARD WOLF (B)(4) AND A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ON OCTOBER 15, 2019, RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION: DURING A HOLEP, THE MORCELLATOR DID NOT WORK. SUCTION WAS NOT POSSIBLE. AS A RESULT, THE OPERATION WAS ABORTED. THE PATIENT WAS GIVEN A BLADDER PROBE. TWO DAYS LATER THE OPERATION WAS COMPLETED. THIS DEVICE REPORTED WAS PRODUCT TYPE NUMBER 2208.001 AND IT IS NOT SOLD IN USA. HOWEVER, AN EQUIVALENT DEVICE IS MARKETED IN THE USA WITH THE PRODUCT TYPE NUMBER 2208011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123674 PIRANHA SUCTION PUMP POWERED SUCTION PUMP JCX RICHARD WOLF GMBH 2208.001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization