BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY FORCEPS (RADIAL JAW 4)

    MDR report key: 837979 · Received April 11, 2007

    Report

    Report Number
    6000150-2007-00036
    Event Type
    Injury
    Date Received
    April 11, 2007
    Date of Event
    March 26, 2007
    Report Date
    March 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - DEVICE NOT RETURNED, AN EVAL WILL NOT BE PERFORMED, DEVICE DISCARDED, UNABLE TO F/U, USER INTERFACE CONTRIBUTED TO EVENT, NO CONCLUSION CAN BE DRAWN (FOR ROOT CAUSE REGARDING SUSPECT DEVICE). SINCE THE LOT NUMBER WAS NOT REPORTED, A SHIP HISTORY WAS PERFORMED AND IDENTIFIED FOUR LOTS WHICH WERE SOLD TO THIS CUSTOMER: 8586040/8697384/8700802/8844836. A DHR REVIEW WAS PERFORMED ON ALL FOUR LOTS AND NO ANOMALIES WERE FOUND IN ANY OF THE FOUR. ALSO, A SIMILAR COMPLAINT REVIEW WAS PERFORMED ON THESE SAME FOUR LOTS. ONE LOT, 8700802, WAS INVOLVED IN ONE COMPLAINT; HOWEVER, DUE TO A DIFFERENT ISSUE (SCOPE DAMAGE). THE DFU FOR THIS PRODUCT STATES: "THESE SINGLE USE BIOPSY FORCEPS SHOULD ONLY BE USED TO BIOPSY TISSUE WHERE POSSIBLE HEMORRHAGE WILL NOT PRESENT A DANGER FOR PTS. ADEQUATE PLANS FOR MANAGEMENT OF POTENTIAL BLEEDING AND APPROPRIATE AIRWAY MANAGEMENT SHOULD BE IN PLACE.", AND, "READ THESE INSTRUCTIONS THOROUGHLY. FAILURE TO FOLLOW INSTRUCTIONS MAY LEAD TO SERIOUS MEDICAL CONSEQUENCES." DETERMINATION OF A ROOT CAUSE CANNOT BE COMPLETED WITHOUT ANALYSIS OF THE SUSPECT DEVICE UNIT. THE FEBRUARY 2007 15-MONTH TREND CHART WAS REVIEWED FOR THE RADIAL JAW 4 BIOPSY FORCEPS PRODUCT FAMILY AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A FEMALE PT (AGE UNK) UNDERWENT A GASTROSCOPIC BIOPSY PROCEDURE INVOLVING A RADIAL JAW 4 BIOPSY FORCEPS DEVICE. NO DEVICE FAILURE WAS REPORTED; HOWEVER, IT WAS REPORTED THAT THE PT EXPERIENCED BLEEDING WHICH REQUIRED ADMITTANCE TO THE ICU FOR AN ADD'L 2 DAYS FOLLOWING THE PROCEDURE. TREATMENT INVOLVED ADMIN OF 2 UNITS OF BLOOD. THE PT WAS DISCHARGED WITH NO OTHER COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE HOSP FORMERLY USED THE RADIAL JAW 3, A BSC FORCEPS DEVICE WHICH PROVIDES A SMALLER JAW OD, AND THAT THE PHYSICIAN STATED THAT THE RADIAL JAW 4 OD IS "TOO BIG WHICH WAS THE CAUSE OF BLEEDING".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization