BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 8568939 · Received May 1, 2019

    Report

    Report Number
    1216677-2019-00065
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE E-COMPLAINT: (B)(4). *INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION: X-NO SAMPLE RETURNED. X-REVIEW DHR. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE 15006-02 FISHER CONE ASSEMBLY WAS PURCHASED FROM GEOTEC, INC. AS AN OEM FINISHED PRODUCT, RECEIVED AT CSI 2/2/2017 AND 3/22/2017, ISSUED TO WORK ORDER: (B)(4) AS CSI PART NUMBER: 900-151 AND COMPLETED 4/7/2017. MANUFACTURING RECORD REVIEW: THE DHR FOR THIS UNIT 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 INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD HAD BEEN ARCHIVED AND NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION. SERVICE HISTORY RECORD. SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE PRODUCT TWO-YEAR HISTORY INDICATED DID NOT REVEAL ANY TRENDS RELATED TO THE DESCRIPTION OF THE REPORTED EVENT. THE REPORTED EVENT WILL BE MONITORED FOR POSSIBLE FUTURE REPORTED EVENT TRENDING. PRODUCT RECEIPT: THE SAMPLE WAS NOT RETURNED AT THE TIME OF THIS INVESTIGATION. VISUAL EVALUATION: THE SAMPLE WAS NOT RETURNED AT THE TIME OF THIS INVESTIGATION AND THUS EVALUATION WAS NOT PERFORMED. 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: COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    "DURING PROCEDURE, WIRE BROKE WHEN THE POWER WAS TURNED ON." 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

    "DURING PROCEDURE, WIRE BROKE WHEN THE POWER WAS TURNED ON." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360929 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL INC. 900-151 219142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other