BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 3

    MDR report key: 2478067 · Received March 5, 2012

    Report

    Report Number
    3005099803-2012-00822
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: GENERATOR : ICC200 (ERBE) SETTING VALUE : 120W, EFFECT 3, SOFT COAGULATION 80. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. FUNCTIONALLY, THE UNIT WAS ABLE TO BE OPENED AND CLOSED WITHOUT ISSUE. ADDITIONALLY, ELECTRICAL RESISTANCE TESTING WAS PERFORMED AND THE FORCEPS DEVICE MET SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-00821 AND 3005099803-2012-00822 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WERE USED DURING A PROCEDURE FOR HEMOSTASIS OF GASTRIC ULCERS WITHIN THE STOMACH, ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO POWER DISTRIBUTION TO THE DEVICE WHEN IT WAS ATTEMPTED TO CAUTERIZE AN EXPOSED VESSEL. THE PHYSICIAN REMOVED THE DEVICE AND TESTED IT USING THE CONTINUITY TESTER OF THE GENERATOR BUT NO ISSUES WERE NOTED. THE DEVICE WAS REINSERTED INTO THE PATIENT BUT THE SAME ISSUE OF NO POWER DISTRIBUTION OCCURRED. A SECOND RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WAS OPENED AND TESTED USING THE CONTINUITY TESTER OF THE GENERATOR BUT THE PHYSICIAN COULD NOT CONFIRM THE CONTINUITY CLEARLY AND THEREFORE THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING AN ARGON-PLASMA COAGULATION (APC) DEVICE. 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-00821 AND 3005099803-2012-00822 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WERE USED DURING A PROCEDURE FOR HEMOSTASIS OF GASTRIC ULCERS WITHIN THE STOMACH, ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO POWER DISTRIBUTION TO THE DEVICE WHEN IT WAS ATTEMPTED TO CAUTERIZE AN EXPOSED VESSEL. THE PHYSICIAN REMOVED THE DEVICE AND TESTED IT USING THE CONTINUITY TESTER OF THE GENERATOR BUT NO ISSUES WERE NOTED. THE DEVICE WAS REINSERTED INTO THE PATIENT BUT THE SAME ISSUE OF NO POWER DISTRIBUTION OCCURRED. A SECOND RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WAS OPENED AND TESTED USING THE CONTINUITY TESTER OF THE GENERATOR BUT THE PHYSICIAN COULD NOT CONFIRM THE CONTINUITY CLEARLY AND THEREFORE THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING AN ARGON-PLASMA COAGULATION (APC) DEVICE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 3 FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00515501 14477863

    Patients

    Seq Age Sex Outcome Treatment
    1