BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC INSUFFLATOR

    MDR report key: 8407943 · Received March 11, 2019

    Report

    Report Number
    1418479-2018-00021
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    July 1, 2018
    Report Date
    August 24, 2018
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HIF
    UDI-DI
    04055207056523
    PMA / PMN Number
    K000180
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS CONTACTED AND ALL AVAILABLE INFORMATION WAS PROVIDED. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION,ON-SITE EVALUATION BY THE SALES REPRESENTATIVE DETERMINED THAT THE ISSUE WAS CAUSED BY A DEFECTIVE OUTLET. DEVICE LABELING WAS REVIEWED FOR PATIENT AND DEVICE CODES: PATIENT CODE: NOT APPLICABLE, NO PATIENT PROBLEM WAS REPORTED. DEVICE CODE: IFU WAS REVIEWED, SEE BELOW: CAUTION! THE TEM PUMP MUST BE ENABLED TO PROPERLY PERFORM THE TEM PROCEDURES! IT IS POSSIBLE TO ENGAGE THE LAPAROSCOPIC INSUFFLATOR FUNCTION WHEN THE TEM CONFIGURATION IS DESIRED. WHEN PERFORMING TEM APPLICATIONS BE SURE THAT THE PUMP INDICATOR IS ILLUMINATED. IF THE PUMP IS NOT ENABLED, THE INSUFFLATOR WILL CYCLE BETWEEN ITS INSUFFLATION AND MEASUREMENT PERIODS. THIS CAN BE DETECTED BY A VISUAL PULSING OF THE GAS FLOW INDICATOR AND AN AUDIBLE PAUSE IN THE INSUFFLATION MODE. IF THIS SITUATION IS DETECTED, CHANGE THE MODE AS WRITTEN IN SECTION 4.8.2. CHECK ALL CONNECTIONS AND ASSURE THAT THE PUMP IS ENABLED. POWER FAILURE - SHOULD THE POWER SUPPLY FAIL: SELECTED MODES ARE STORED FOR APPROX. 20 S. WHEN THE POWER SUPPLY IS RESTORED: POWER FAILURE FOR LESS THAN 20 SECONDS: THE APPLICATION IS CONTINUED WITH THE SETTINGS PREVIOUSLY SELECTED. IF THE POWER FAILURE IS LONGER THAN 20 SECONDS: THE LAPARO CO2 PNEU RUNS THROUGH THE AUTOMATIC FUNCTION TEST. RW (B)(4) CONSIDERS THIS CASE CLOSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 24 AUGUST 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED MEDWATCH REPORT # (B)(4). THE FOLLOWING WAS REPORTED: "PATIENT SCHEDULED FOR A TRANSANAL ENDOSCOPIC MICROSURGICAL EXCISION OF THE RECTAL TUMOR USING THE WOLF TEM MACHINE. THE PATIENT WAS INTUBATED AND A PROCTOSIGMOIDOSCOPY WAS PERFORMED BY THE SURGEON AND THEN THE PATIENT WAS POSITIONED AND PREPPED FOR SURGERY. WHEN IT CAME TIME TO START THE MACHINE ONLY THE TOP UNIT WAS LIGHTING UP AND WORKING (INSUFFLATOR). THE BOTTOM UNIT DID NOT TURN ON. OTHER STAFF CAME INTO THE ROOM TO TROUBLESHOOT THE PROBLEM WITH NO LUCK GETTING THE BOTTOM UNIT TO TURN ON. THE WOLF REP, AND TEAM LEADER WAS CALLED TO HELP TROUBLESHOOT. AT THIS TIME THE SURGEON WANTED TO ABORT THE CASE." THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SALES REPRESENTATIVE WENT TO THE USER FACILITY TO INVESTIGATE THE REPORTED ISSUE AND FOUND THAT THE CAUSE OF THE PROBLEM WAS A DEFECTIVE OUTLET. THE UNIT WAS PLUGGED INTO A DIFFERENT OUTLET AND BEGAN WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200715 LAPAROSCOPIC INSUFFLATOR LAPAROSCOPIC INSUFFLATOR HIF RICHARD WOLF GMBH 2232.641 04055207056523

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other