BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEM PUMP 2232

    MDR report key: 1202498 · Received October 8, 2008

    Report

    Report Number
    1418479-2008-00024
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 8, 2008
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    FJL
    PMA / PMN Number
    K000180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE 03/2008 WAS THE INITIAL RECEIVING DATE THAT RICHARD WOLF MEDICAL INSTRUMENTS RECEIVED THE DEVICE FROM INTERNATIONAL AFFILIATE. METHOD - A HEX WRENCH WAS USED TO CHECK THE SCREW ON THE DEVICE. EVAL SUMMARY: 2232.644 TEM (TRANSANAL ENDOSCOPIC MICROSURGERY) PUMP. VISUAL INSPECTION OF THE TEM PUMP SHOWED THAT THE HEX SCREW HAD BEEN RE-INSERTED PRIOR TO RECEIPT. THE MFR HAS BEEN INFORMED, AND WILL REPAIR PUMP ROLLER ASSEMBLY. THIS IS THE FIRST COMPLAINT OF THIS TYPE WITH THIS DEVICE. OUR RICHARD WOLF SALES REP AND OUR CLINICAL SALES SPECIALISTS WAS THERE FOR THE PROCEDURE TO ASSIST. A CAPA HAS BEEN INITIATED BY RICHARD WOLF MEDICAL INSTRUMENTS FOR CORRECTIVE AND PREVENTATIVE ACTION. USER FACILITY RETURNED THE 2232.641 INSUFFLATOR THAT WAS USED IN CONJUNCTION WITH THE PUMP. THE INSUFFLATOR FUNCTIONED PER SPECIFICATION. THE FAILURE WAS NOT ASSOCIATED WITH THE INSUFFLATOR. CAUSE OF EVENT: COMPONENT (HEX SCREW) BECAME LOOSE DUE TO BONDING FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TEM PROCEDURE A SCREW FELL OFF THE PUMP ROLLER. THE SCREW WAS ADJUSTED IN ORDER FOR PUMP TO WORK. THERE WAS A 20-30 MINUTE DELAY IN THE PROCEDURE. THE ANESTHESIA FOR PT WAS INCREASED. THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEM PUMP 2232 TEM PUMP 2232 FJL RICHARD WOLF MEDICAL INSTRUMENTS 2232.644

    Patients

    Seq Age Sex Outcome Treatment
    1