BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER PNEUMO SURE INSUFFLATION TUBING

    MDR report key: 8459752 · Received March 27, 2019

    Report

    Report Number
    MW5085256
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Manufacturer
    STRYKER CORP
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SDS OPENED A STRYKER PNEUMO SURE INSUFFLATION TUBING, REF#: 0620-040-690, LOT#: 18E0177, EXP. DATE: 2021-05-01, M#: 3618609, AND WHEN IT WOULD NOT CONNECT TO THE INSUFFLATOR MACHINE, NOTICED THE PLASTIC WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248158 STRYKER PNEUMO SURE INSUFFLATION TUBING INSUFFLATOR LAPARASCOPIC HIF STRYKER CORP 3618609 18E0177

    Patients

    Seq Age Sex Outcome Treatment
    1