BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    MDR report key: 3230481 · Received July 16, 2013

    Report

    Report Number
    0002936485-2013-00300
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K063367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOT HYSTERECTOMY INSUFFLATION WAS LOST. SEVERAL REPLACEMENT TUBINGS FROM DIFFERENT LOTS WERE TRIED AND DID NOT WORK. FURTHER A MOBILE CART WITH A CO2 TANK WAS BROUGHT IN AND ATTEMPTED. NO INSUFFLATION WAS GAIN USING ALL OF THESE METHODS, SO WENT TO AN OPEN PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOT HYSTERECTOMY INSUFFLATION WAS LOST. SEVERAL REPLACEMENT TUBINGS FROM DIFFERENT LOTS WERE TRIED AND DID NOT WORK. FURTHER A MOBILE CART WITH A CO2 TANK WAS BROUGHT IN AND ATTEMPTED. NO INSUFFLATION WAS GAIN USING ALL OF THESE METHODS, SO WENT TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328135 PNEUMO SURE XL HIGH FLOW INSUFFLATOR INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1