BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU2)

    MDR report key: 3854367 · Received June 6, 2014

    Report

    Report Number
    0002936485-2014-00399
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K063367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: POWER SUPPLY MALFUNCTION, UNWANTED MOVEMENT OF INTERNAL COMPONENTS / WIRING, USE ERROR, MANUFACTURING/ASSEMBLY ERROR, SYSTEM DESIGN. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED AT STRYKER ENDOSCOPY FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE GAS HOSE WAS PLACED PARTIALLY ON THE PATIENT'S SKIN AND ABOVE THE SURGICAL DRAPES. BURN MARKS WERE FOUND ON THE PATIENT AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE GAS HOSE WAS PLACED PARTIALLY ON THE PATIENT'S SKIN AND ABOVE THE SURGICAL DRAPES. BURN MARKS WERE FOUND ON THE PATIENT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331956 PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU2) INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1