BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION NEEDLE

    MDR report key: 2062684 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01293
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K953338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE REPORT OF THE NEEDLE FAILING TO RETRACT WAS NOT ABLE TO BE CONFIRMED. THE RETURNED OPTILFLO INJECTION NEEDLE DEVICE WAS EXAMINED. A VISUAL INSPECTION FOUND NO ISSUES. A FUNCTIONAL TEST FOUND NO PROBLEMS IN ADVANCING AND RETRACTING NEEDLE USING THUMB RING; THE NEEDLE ENTERED AND CAME OUT OF THE SHEATH COMPLETELY. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTILFLO INJECTION NEEDLE DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE COLONOSCOPY, THE NEEDLE WAS USED TO MARK THE POLYP LOCATION. HOWEVER, AFTER INJECTING THE DYE, THE NEEDLE FAILED TO RETRACT. THE NEEDLE WAS SLOWLY WITHDRAWN FROM THE COLONOSCOPE AND ANOTHER OPTIFLO INJECTION NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTILFLO INJECTION NEEDLE DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE COLONOSCOPY, THE NEEDLE WAS USED TO MARK THE POLYP LOCATION. HOWEVER, AFTER INJECTING THE DYE, THE NEEDLE FAILED TO RETRACT. THE NEEDLE WAS SLOWLY WITHDRAWN FROM THE COLONOSCOPE AND ANOTHER OPTIFLO INJECTION NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION NEEDLE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00511731 0000716904

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR