BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2190708 · Received July 29, 2011

    Report

    Report Number
    MW5021570
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN GI SUITES FOR UPPER ENDOSCOPY AND PLACEMENT OF GASTRIC FEEDING TUBE. AT THE END OF THE PROCEDURE, THE SCALPEL FROM THE 20 FR. SAFETY PEG KIT, PUSH METHOD, DID NOT RETRACT AND SCALPEL BLADE FELL OUT. THERE WAS NO HARM TO THE PT WO HAD SUCCESSFUL PLACEMENT OF HIS GASTRIC FEEDING TUBE, TOLERATED THE PROCEDURE WELL, AND WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC 20 FR. SAFETY PEG KIT, PUSH METHOD KNT BOSTON SCIENTIFIC 14380944

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR