BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2103397 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01812
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. CONCOMITANT MEDICAL PRODUCT: OLYMPUS CLIP. 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 DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A SUPERFICIAL TEAR OF THE MUCOSA WAS NOTED AFTER ONE BIOPSY WAS TAKEN FROM THE ASCENDING COLON. WHEN THE BIOPSIES WERE COMPLETED, A RESOLUTION CLIP WAS USED TO TRY AN CLOSE THE SUPERFICIAL TEAR, HOWEVER, THE CLIP SLIPPED OFF THE MUCOSA. THE BIOPSY PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 BIOPSY DEVICE AND A DIFFERENT DEVICE WAS USED TO CLOSE THE MUCOSA. THE PATIENT HAD AN UNCOMPLICATED RECOVERY AND WAS ROUTINELY DISCHARGED. 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

    ADDITIONAL INFORMATION: THE USER REPORTED THAT BLEEDING OCCURRED AFTER TAKING A BIOPSY IN THE ASCENDING COLON. REPORTEDLY, THE RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS NOT INSPECTED/TESTED PRIOR TO USE. ADDITIONALLY, THE RESOLUTION CLIP DETACHED FROM THE MUCOSA IN A CLOSED STATE AND WAS LEFT TO PASS NATURALLY.

    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 M00513402 0014036766

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention