BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX NEEDLE KNIFE XL

    MDR report key: 2771745 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04565
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K973826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE WAS IN THE RETRACTED POSITION. THE WORKING LENGTH OF THE DEVICE WAS FOUND TO BE BENT AND THE TIP WAS MELTED AND CHARRED/BLACKENED. FUNCTIONAL EVALUATION FOUND THAT THE NEEDLE COULD NOT BE EXTENDED OUT OF THE CATHETER TIP WHEN THE HANDLE WAS ACTIVATED. THE DISTAL TIP OF THE DEVICE WAS CUT TO EXPOSE THE NEEDLE; THE NEEDLE WAS MEASURED TO BE 24 MM WHICH DOES NOT MEET THE SPECIFICATION OF 28.00 MM ± 0.500. THE DISTAL END OF THE BROKEN CUT WIRE WAS BLACKENED/BURNT AND THE DISTAL SECTION OF THE BROKEN CUT WIRE WAS NOT RETURNED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE NEEDLE BROKE. THE OTHER WARNINGS SECTION OF THE DIRECTIONS FOR USE (DFU) STATES 'USE THE MONOPOLAR GENERATOR'S RECOMMENDED POWER SETTING FOR SPHINCTEROTOMY. EXCESS POWER MAY LEAD TO PATIENT INJURY, OR MAY DAMAGE INTEGRITY OF CUTTING WIRE.' HOWEVER, ACCORDING TO THE COMPLAINANT, 'GENERATOR SETTINGS WERE TURNED UP HIGHER THAN THEY SHOULD HAVE BEEN.' REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS "USER/USE ERROR". A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT: NEEDLE DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEEDLEKNIFE RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BOVIE GENERATOR SETTINGS WERE TURNED UP HIGHER THAN THEY SHOULD HAVE BEEN AND THE END OF THE NEEDLEKNIFE WAS BURNT. THE NEEDLE BROKE OFF INSIDE THE PATIENT. THE CATHETER WAS REMOVED AND NO ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE. THE PHYSICIAN DID NOT EXPRESS CONCERN OVER THE DETACHED NEEDLE. THE PROCEDURE WAS COMPLETED WITH A HYDRATOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEEDLEKNIFE RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BOVIE GENERATOR SETTINGS WERE TURNED UP HIGHER THAN THEY SHOULD HAVE BEEN AND THE END OF THE NEEDLEKNIFE WAS BURNT. THE NEEDLE BROKE OFF INSIDE THE PATIENT. THE CATHETER WAS REMOVED AND NO ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE. THE PHYSICIAN DID NOT EXPRESS CONCERN OVER THE DETACHED NEEDLE. THE PROCEDURE WAS COMPLETED WITH A HYDRATOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE 'FINE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX NEEDLE KNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545840 0015295847

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR