BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY FORCEPS (RADIAL JAW 4)

    MDR report key: 858295 · Received June 1, 2007

    Report

    Report Number
    6000150-2007-00048
    Event Type
    Injury
    Date Received
    June 1, 2007
    Date of Event
    April 26, 2007
    Report Date
    May 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FCL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSIONS: DEVICE NOT RETURNED, AN EVALUATION WILL NOT BE PERFORMED.DEVICE DISCARDED, UNABLE TO FOLLOW-UP. NO CONCLUSION CAN BE DRAWN (FOR ROOT CAUSE REGARDING SUSPECT DEVICE). A SIMILAR COMPLAINT REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER, 8905611, AND IDENTIFIED ONE OTHER COMPLAINT FOR THIS LOT WHICH WAS REPORTED BY THE SAME CUSTOMER FOR BIOPSY SITE BLEEDING WHICH DID NOT REQUIRE INTERVENTION. THE APRIL 2007 ROLLING 15 MONTH COMPLAINT TREND CHART WAS REVIEWED FOR THE RJ4 PRODUCT FAMILY. NO ADVERSE TRENDS WERE NOTED. FURTHER, THE TOTAL NUMBER OF COMPLAINTS RECEIVED FOR THIS PRODUCT FAMILY DOES NOT EXCEED A LIMIT WHICH WOULD WARRANT FURTHER ACTION AT THIS TIME. THE COMPLAINANT HAS REPORTED THAT THE PRODUCT WILL NOT BE RETURNED SINCE IT WAS DISPOSED; THEREFORE, AN EVALUATION WILL NOT BE CONDUCTED AND THE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A PATIENT (AGE AND GENDER UNKNOWN) UNDERWENT AN ESOPHAGEAL BIOPSY PROCEDURE USING A RADIAL JAW 4 BIOPSY FORCEPS DEVICE. IT WAS REPORTED THAT FOLLOWING THE BIOPSY THERE WAS AN INCREASED AMOUNT OF BLEEDING AT THE BIOPSY SITE. THE PHYSICIAN SUCCESSFULLY TREATED THE BLEED USING AN INJECTION OF ADRENALIN AND HEMOSTASIS CLIPS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND RECOVERED OVERNIGHT. NO FURTHER COMPLICATIONS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY FORCEPS (RADIAL JAW 4) FCL FCL BOSTON SCIENTIFIC CORP. 1331-20 8905611

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R