BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1905035 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04831
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, GENDER AND WEIGHT ARE UNKNOWN. THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, THE PATIENT WAS REPORTED TO BE OVER 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) - (INTERVENTION REQUIRED TO STOP BLEED). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BIOPSY FORCEPS WERE INSERTED THROUGH THE ENDOSCOPE AND POSITIONED WITHIN THE ESOPHAGUS TO OBTAIN BIOPSY SAMPLES. HOWEVER, THE PHYSICIAN REPORTED THAT THE BITES TAKEN BY THE FORCEPS WERE TOO LARGE. DURING ONE BITE, THE FORCEPS PIERCED THROUGH THE MUCOSA INTO A BLOOD VESSEL CAUSING AN ACTIVE BLEED. A RESOLUTION CLIP WAS USED TO SUCCESSFULLY CONTROL THE BLEED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention