BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEP, REPROCESSED

    MDR report key: 8639691 · Received May 24, 2019

    Report

    Report Number
    8639691
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    June 29, 2018
    Report Date
    May 22, 2019
    Manufacturer
    STERILMED, INC.
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A POLYP THAT NEEDED TO BE REMOVED WITH A BIOPSY FORCEP. BIOPSY FORCEP WAS GIVEN TO ME BY TECH. THE BIOPSY FORCEP WAS NON-FUNCTIONAL AND BROKEN. THE TIP WAS DEFORMED. THE METALLIC TIP WAS DISSOCIATED FROM THE ORANGE PLASTIC SHEATH. THIS WAS ONE OF OUR "REPROCESSED" BIOPSY FORCEPS. ACTION TAKEN: I ASKED FOR A NEW BIOPSY FORCEP, WAS GIVEN A NEW ONE, AND REMOVED THE POLYP WITHOUT INCIDENT. PRODUCT RE-STERILIZATION WITH STERILMED. SPOKE WITH DOCTOR: HAPPENS FREQUENTLY. INVESTIGATION WITH OTHER GI DOCS: ALSO HAPPENING FREQUENTLY AND ONE STATED TIP BROKE IN PATIENT COLON. DECISION MADE TO IMMEDIATELY STOP USING AND BUY DIRECTLY FROM ANOTHER MANUFACTURER. SAMPLE GIVEN TO SUPPLY COORDINATOR AS A VISUAL FOR HIS TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433892 FORCEP, REPROCESSED REPROCESSED BIOSPY FORCEPS FCL STERILMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1