BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 3901042 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02441
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF GENERATOR OUTPUT ISSUES. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED UNIT FOUND THAT THE DEVICE WAS IN GOOD CONDITION WITH SOME MINOR SCRATCHES ON THE COVER. A FUNCTIONAL EVALUATION REVEALED THAT ALL THE KNOBS AND SWITCHES APPEAR TO FUNCTION PROPERLY HOWEVER, THE MONOPOLAR CONNECTOR APPEARED TO BE LOOSE. ELECTRICAL EVALUATION WAS PERFORMED AND THE UNIT WAS FOUND TO BE WITHIN TEST PARAMETERS. THE COMPLAINT THAT THE MONOPOLAR COAG MODE HAS INTERMITTENT OUTPUT WAS NOT CONFIRMED. IT WAS CONFIRMED THAT THE LOOSE MONOPOLAR CONNECTION WAS NOT CAUSING ANY OUTPUT PROBLEMS. THE RETURNED DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE, NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A DHR REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND DURING ORIGINAL MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOSTAT III RF GENERATOR WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR WAS SET ON "CONTROL CUT" AT 90W BUT THE GENERATOR DID NOT PRODUCE ENOUGH CURRENT TO PERFORM A SPHINCTEROTOMY. ALL CONNECTIONS WERE CHECKED BUT STILL THE GENERATOR WOULD NOT CUT . THE MODE WAS THEN CHANGED TO "BLEND" AT 30W BUT THE DEVICE STILL WOULD NOT CUT. THE ACCESSORY DEVICE WAS THEN CHANGED TO A NEEDLE KNIFE AND THE OUTPUT WAS INCREASED TO 35W. ALTHOUGH THE DEVICE DID FINALLY CUT, IT REPORTEDLY CUT "WAY TOO MUCH." HOWEVER, IT WAS REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOSTAT III RF GENERATOR WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR WAS SET ON "CONTROL CUT" AT 90W BUT THE GENERATOR DID NOT PRODUCE ENOUGH CURRENT TO PERFORM A SPHINCTEROTOMY. ALL CONNECTIONS WERE CHECKED BUT STILL THE GENERATOR WOULD NOT CUT . THE MODE WAS THEN CHANGED TO "BLEND" AT 30W BUT THE DEVICE STILL WOULD NOT CUT. THE ACCESSORY DEVICE WAS THEN CHANGED TO A NEEDLE KNIFE AND THE OUTPUT WAS INCREASED TO 35W. ALTHOUGH THE DEVICE DID FINALLY CUT, IT REPORTEDLY CUT "WAY TOO MUCH". HOWEVER, IT WAS REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380970 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200R0

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR