BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW

    MDR report key: 9201996 · Received October 17, 2019

    Report

    Report Number
    9201996
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 15, 2019
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IRRIGATION TUBING COMES APART FROM THE BATTERY PACK CAUSING INTRAVENOUS FLUID TO LEAK OVER THE BATTERY PACK. THERE WAS NO HARM TO ANY PATIENT OR PROVIDER. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, STRYKEFLOW (PER SITE REPORTER). THEY WOULD LIKE TO LEARN OF THE FAILURE AND INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998500 STRYKEFLOW LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ STRYKER ENDOSCOPY 0250070500 19141FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA