BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 1832664 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03910
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ERBE EUS MACHINE - SET ON HOT BIOPSY COLON SETTING.COOK ACTIVE CORD (UNIVERSAL ACU-1-VL G22092)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. SIMILARLY, THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND IT PERFORMED ACCORDING TO SPECIFICATIONS. ELECTRICAL RESISTANCE TESTING WAS ALSO PERFORMED AND THE DEVICE MEASURED ACCORDING TO SPECIFICATION. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE THE COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ABNORMALITIES, VISUAL OR FUNCTIONAL THEREFORE, THE MOST PROBABLE ROOT CAUSE COULD NOT BE CONFIRMED AS THE RETURNED DEVICE WAS WITHIN MANUFACTURING SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY / POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PHYSICIAN WAS REMOVING THE POLYP, THE TISSUE (APPROXIMATELY 1CM PROXIMALLY) WAS LIGHTLY BURNED. IT LOOKED AS THOUGH A SPARK OR SURGE OF HEAT CAME THROUGH THE SHEATH, BUT THERE WAS NO VISIBLE BREAKAGE OR EXPOSED WIRES. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY, THE PRODUCT WAS INSPECTED PRIOR TO USE AND THERE WERE NO APPARENT DEFECTS. 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 RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY / POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PHYSICIAN WAS REMOVING THE POLYP, THE TISSUE (APPROXIMATELY 1CM PROXIMALLY) WAS LIGHTLY BURNED. IT LOOKED AS THOUGH A SPARK OR SURGE OF HEAT CAME THROUGH THE SHEATH, BUT THERE WAS NO VISIBLE BREAKAGE OR EXPOSED WIRES. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY THE PRODUCT WAS INSPECTED PRIOR TO USE AND THERE WERE NO APPARENT DEFECTS. 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 HOT BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515503 0013013630

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other