BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 2072523 · Received April 29, 2011

    Report

    Report Number
    3005099803-2011-01473
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 20, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE RETURNED INJECTION GOLD PROBE DEVICE WAS RETURNED WITHOUT THE DISTAL PORTION OF THE CERAMIC TIP. THE INNER AND OUTER DIAMETER OF THE CATHETER WAS MEASURED, AND FOUND TO BE WITHIN SPECIFICATION. AS THE TIP WAS NOT ATTACHED, THE DEVICE CAN NOT BE USED FOR CAUTERY. THE ROOT CAUSE IS CONSIDERED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 AN INJECTION GOLD PROBE DEVICE WAS USED DURING A GASTROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THAT THE INJECTION GOLD PROBE DEVICE WAS STIFFER THAN USUAL TO GET DOWN THE SCOPE. ONCE AT THE BLEED SITE, THEY EXTENDED THE NEEDLE AND INJECTED 4 MLS OF ADRENALINE. THE NEEDLE WAS RETRACTED AND ELECTROCAUTERY WAS APPLIED. IT WAS NOTICED THAT THE ELECTROCAUTERY DID NOT SEEM TO BE WORKING AS WELL AS IT SHOULD. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE INJECTION GOLD PROBE DEVICE, AND THE BLEEDING STOPPED. AS THE NURSE WAS TAKING THE DEVICE OUT OF THE SCOPE THE SHEATH TIP CAME OFF THE END OF THE PROBE. IT WAS SITTING IN THE BIOPSY CAP LEAVING THE NEEDLE BARE AT THE END OF THE INJECTION GOLD PROBE. 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 INJECTION GOLD PROBE DEVICE WAS USED DURING A GASTROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THAT THE INJECTION GOLD PROBE DEVICE WAS STIFFER THAN USUAL TO GET DOWN THE SCOPE. ONCE AT THE BLEED SITE, THEY EXTENDED THE NEEDLE AND INJECTED 4 MLS OF ADRENALINE. THE NEEDLE WAS RETRACTED AND ELECTROCAUTERY WAS APPLIED. IT WAS NOTICED THAT THE ELECTROCAUTERY DID NOT SEEM TO BE WORKING AS WELL AS IT SHOULD. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE INJECTION GOLD PROBE DEVICE, AND THE BLEEDING STOPPED. AS THE NURSE WAS TAKING THE DEVICE OUT OF THE SCOPE THE SHEATH TIP CAME OFF THE END OF THE PROBE. IT WAS SITTING IN THE BIOPSY CAP LEAVING THE NEEDLE BARE AT THE END OF THE INJECTION GOLD PROBE. 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 INJECTION GOLD PROBE DEVICE WAS USED DURING A GASTROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THAT THE INJECTION GOLD PROBE DEVICE WAS STIFFER THAN USUAL TO GET DOWN THE SCOPE. ONCE AT THE BLEED SITE, THEY EXTENDED THE NEEDLE AND INJECTED 4 MLS OF ADRENALINE. THE NEEDLE WAS RETRACTED AND ELECTROCAUTERY WAS APPLIED. IT WAS NOTICED THAT THE ELECTROCAUTERY DID NOT SEEM TO BE WORKING AS WELL AS IT SHOULD. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE INJECTION GOLD PROBE DEVICE, AND THE BLEEDING STOPPED. AS THE NURSE WAS TAKING THE DEVICE OUT OF THE SCOPE THE SHEATH TIP CAME OFF THE END OF THE PROBE. IT WAS SITTING IN THE BIOPSY CAP LEAVING THE NEEDLE BARE AT THE END OF THE INJECTION GOLD PROBE. 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 GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI M00560150 0013544129

    Patients

    Seq Age Sex Outcome Treatment
    1