BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSEWAVE SNGL SPIKE NO PROBE

    MDR report key: 1944821 · Received January 3, 2011

    Report

    Report Number
    8030673-2011-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 3, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED ISSUE. THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. AN INTERNAL TECHNICAL SUMMARY (B)(4) HAS BEEN INITIATED TO DETERMINE IF ANY CORRECTIVE OR PREVENTATIVE ACTIONS SHOULD BE INITIATED AND WILL BE APPLIED IF ADDITIONAL DATA OR SAMPLES BECOME AVAILABLE.

    Description of Event or Problem · 1

    FOUR REPORTED GENERAL INCIDENTS OF SUCTION BUTTON ON THE PULSEWAVE SUCTION IRRIGATOR STICKING IN THE DOWN POSITION, CAUSING EVACUATION OF THE PNEUMOPERITONEUM AND IRRIGATION PROBE STICKING TO THE BOWEL. THERE WAS NO INJURY TO THE PATIENT(S) AND NO ADDED MEDICAL OR SURGICAL TREATMENT REQUIRED OR REQUESTED. THE PROBLEM ENCOUNTERED WAS AN ESTIMATED FIVE TO TEN MINUTE PROLONGATION IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSEWAVE SNGL SPIKE NO PROBE PULSEWAVE SNGL SPIKE NO PROBE GBX CARDINAL HEALTH ASC1220 Y10L2543, Y10N1447

    Patients

    Seq Age Sex Outcome Treatment
    1