BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1911415 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-04968
    Event Type
    Injury
    Date Received
    December 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. EVENT DATE IS UNKNOWN. (B)(4) - INTERVENTION REQUIRED TO REMOVE JAW. (B)(4) - REPORTED EVENT OF JAW DETACHMENT. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BIOPSY FORCEPS WERE INTRODUCED INTO THE SCOPE IN THE CLOSED POSITION. HOWEVER, AS THE BIOPSY FORCEPS EXITED THE SCOPE, THE JAWS WERE IN THE OPEN POSITION AND THE JAW SNAPPED OFF AND FELL INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIECE FROM THE PATIENT WITH BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. 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 VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515362 0013520302

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention