BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 7492349 · Received May 7, 2018

    Report

    Report Number
    1216677-2018-00020
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    May 3, 2018
    Report Date
    December 5, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT - INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED, REVIEW DHR. ANALYSIS AND FINDINGS: THE REPORTED COMPLAINT EVENT CANNOT BE CONFIRMED OR VERIFIED AS THE AFFECTED VAD SAMPLE WAS NOT BE RETURNED FOR ANALYSIS AS OF THE TIME OF THIS INVESTIGATION. IT WAS SCHEDULED TO BE RETURNED BY 5/30/2018. HOWEVER, ID THE SAMPLE DEVICE IS RETURNED IN THE FUTURE AND MADE AVAILABLE FOR INVESTIGATIVE ROOT CAUSE ANALYSIS, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. A REVIEW OF THE LOT DHR (ATTACHED) DID NOT INDICATE ANY ABNORMALITY OF THE ASSEMBLY OR IN-PROCESS TESTING. THE TWO-YEAR COMPLAINT HISTORY WAS ALSO REVIEWED AND INDICATED THIS TO BE THE FIRST REPORTED INCIDENT OF ITS TYPE. CORRECTION AND/OR CORRECTIVE ACTION: NONE -CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME AS THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATIVE ANALYSIS. THE REPORTED EVENT WILL BE MONITORED FOR TRENDING. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    "HE REPORTED AN INCIDENT WITH PART 900-151 THAT IT "EXPLODED" DURING A PROCEDURE. AS PER PHONE CONVERSATION 5/4/2018 (B)(6) STATED, "THE MALFUNCTION HAPPENED DURING A PROCEDURE OF A LEEP CONE BIOPSY. A FEW MINUTES WERE ADDED ONTO THE PROCEDURE BECAUSE THE DOCTOR HAS TO GO IN AND RETRIEVE THE PIECES IN THE BODY WHICH HE DID SUCCESSFULLY. THE PATIENT WAS NOT INJURED."

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "HE REPORTED AN INCIDENT WITH PART 900-151 THAT IT "EXPLODED" DURING A PROCEDURE." AS PER PHONE CONVERSATION (B)(6) 2018 (B)(6) STATED, "THE MALFUNCTION HAPPENED DURING A PROCEDURE OF A LEEP CONE BIOPSY. A FEW MINUTES WERE ADDED ONTO THE PROCEDURE BECAUSE THE DOCTOR HAS TO GO IN AND RETRIEVE THE PIECES IN THE BODY WHICH HE DID SUCCESSFULLY. THE PATIENT WAS NOT INJURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332142 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 225649

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention