BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDNE SMART 40L CORE INSUFFLATOR

    MDR report key: 1040159 · Received May 7, 2008

    Report

    Report Number
    2936485-2008-00033
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 16, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE SALES REP REPORTS THAT HE WOULD LIKE THE INSUFFLATOR EVALUATED BECAUSE THERE WAS AN INCIDENT AT THE ACCOUNT DURING A LAPAROSCOPIC EPIDECTIMY CASE. THERE WAS A PT INVOLVED THAT WENT INTO CARDIAC ARREST TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDNE SMART 40L CORE INSUFFLATOR INSUFFLATOR HIF STRYKER ENDOSCOPY SAN JOSE 0707CE562

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other