BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX LG S

    MDR report key: 8663947 · Received June 3, 2019

    Report

    Report Number
    1216677-2019-00164
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 21, 2019
    Report Date
    May 25, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF E-COMPLAINT-(B)(4). INVESTIGATION : X-INITIATED MANUFACTURER'S INVESTIGATION, X-REVIEW DHR , X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM GEO TECH, PACKAGED BY CSI ON 11/22/2016 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR-900-155-212090 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. IF THE INCOMING INSPECTION RECORD SHOULD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD : SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS RECEIVED, VERIFIED, AND CONFIRMED FOR THE REPORTED EVENT. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT WAS PERFORMED AND REPORTED COMPLAINT EVENT WAS CONFIRMED. FUNCTIONAL EVALUATION: FUNCTIONAL EVALUATION IS NOT APPLICABLE TO THIS COMPLAINT. ROOT CAUSE: DEFINITIVE ROOT CAUSE IS INDETERMINABLE HOWEVER, PREVIOUS TESTING PERFORMED IN 2011 IN TRYING TO REPLICATE REPORTED EVENTS OF THE WIRE "BURNING" OR "SNAPPING" INDICATED THE PRODUCT PERFORMED AS INTENDED, THE TESTING WAS REPEATED IN MARCH OF 2019 AND RESULTED IN THE SAME MANNER. CORRECTION AND/OR CORRECTIVE ACTION : CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. SEE ATTACHED COPIES OF TESTING REPORTS.

    Description of Event or Problem · 0

    "DOCTOR WENT TO USE THEM AND THE WIRE BROKE OFF. " REF E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "DOCTOR WENT TO USE THEM AND THE WIRE BROKE OFF. " (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457093 FISCHER CONE BIOP EX LG S FISCHER CONE BIOP EX LG S HGI COOPERSURGICAL, INC. 900-155 212090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other