BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMED INSTRUMENTATION INC

    MDR report key: 385011 · Received March 26, 2002

    Report

    Report Number
    385011
    Event Type
    Malfunction
    Date Received
    March 26, 2002
    Date of Event
    March 21, 2002
    Report Date
    March 25, 2002
    Manufacturer
    PRIMED INSTRUMENTS INC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING AN UPPER GI ENDOSCOPY IN THE GI LAB. ONE HALF OF AN ENDOSCOPY BIOPSY FORCEP CUP BROKE OFF DURING THE PROCEDURE AND REMAINED IN PT. THE SMALL BIOPSY CUP COULD NOT BE RETRIEVED. PT WAS INFORMED THAT PT WOULD PASS IT. NO KNOWN PT ADVERSE OUTCOME AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMED INSTRUMENTATION INC ENDOSCOPIC BIOPSY FORCEP KNW PRIMED INSTRUMENTS INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other