BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 9770793 · Received February 28, 2020

    Report

    Report Number
    1216677-2020-00065
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 19, 2020
    Report Date
    February 1, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937003710
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION. DISTRIBUTION HISTORY THE 15006-02 FISHER CONE ASSEMBLY WAS PURCHASED FROM GEOTEC, INC. AS AN OEM FINISHED PRODUCT AND ISSUED TO WORK ORDER (B)(4) AS CSI PART NUMBER 900-151 AND COMPLETED 07/30/2018. 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 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 RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE PRODUCT TWO-YEAR HISTORY INDICATED DID NOT REVEALED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT UNIT WAS NOT RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AT THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDING TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AT THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDING TO THIS INVESTIGATION. 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. SEE ATTACHED COPIES OF TESTING REPORTS. CORRECTIVE ACTIONS COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    REPORTED BY SERVICE AND REPAIR: "THE WIRES BROKE DURING USE". 900-151 FISCHER CONE BIOP EX MED E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. REF E-COMPLAINT: (B)(4).

    Description of Event or Problem · 1

    REPORT SUBMITTED BY CSI SERVICE & REPAIRS STATED "THE WIRES BROKE DURING USE." REF E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235554 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 251785 00888937003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other