BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 JUMBO BIOPSY FORCEPS

    MDR report key: 1019405 · Received March 25, 2008

    Report

    Report Number
    3005099803-2008-00295
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVAL. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE LOT # WAS NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE CUSTOMER'S SHIPMENT HISTORY WAS REVIEWED. THIS IDENTIFIED THREE LOTS (9830231, 11319159 AND 11179603) THAT WERE SHIPPED TO THE CUSTOMER PRIOR TO THE EVENT DATE. A REVIEW OF THE DEVICE HISTORY RECORD FOR EACH LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED ONE ADD'L COMPLAINT WAS REPORTED FOR LOT 9830231 FOR A DIFFERENT FAILURE MODE (BROKEN PULL WIRES). NO ADD'L COMPLAINTS WERE REPORTED FOR LOTS 11319159 AND 11179603. THE 2008 15-MO RADIAL JAW 4 BIOPSY FORCEPS PROD FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A RADIAL JAW 4 JUMBO BIOPSY FORCEPS DEVICE WAS USED IN AN SOPHAGOGASTRODUODENOSCOPY PROCEDURE ON A FEMALE PT IN 2008. ACCORDING TO THE COMPLAINANT, "AFTER A BIOPSY WAS TAKEN FROM THE DUODENUM, THE PT BLED A LOT. THE PHYSICIAN (STATED THAT) THIS PROD WAS TOO BIG AND TOOK TOO LARGE A BITE. THE WRONG ONE WAS TAKEN OUT DURING PREPARATION AND THEY FEEL THE LABELING (IS UNCLEAR) BETWEEN THE JUMBO AND LARGE PACKAGES (AND) THAT (THIS) CAUSED THE ERROR." IT WAS FURTHER REPORTED THAT: "THE PT IS IN INTENSIVE CARE AND HAS REC'D 7 UNITS OF BLOOD..." NO ADD'L INFO HAS BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC CONCERNING THE PT'S PRESENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 JUMBO BIOPSY FORCEPS KNW BOSTON SCIENTIFIC CORPORATION M00513372 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R