BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 10440637 · Received August 23, 2020

    Report

    Report Number
    1216677-2020-00189
    Event Type
    Malfunction
    Date Received
    August 23, 2020
    Date of Event
    August 5, 2020
    Report Date
    February 2, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937003710
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INITIATED MANUFACTURER'S INVESTIGATION. NO SAMPLE RETURNED. DISTRIBUTION HISTORY THE 15006-02 FISHER CONE ASSEMBLY WAS PURCHASED FROM GEOTEC, INC. AS AN OEM FINISHED PRODUCT, ISSUED TO WORK ORDER (B)(4) AS CSI PART NUMBER 900-151 AND COMPLETED 3/6/2020. MANUFACTURING RECORD REVIEW DHR(B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC RECORD-20-03-02-024 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED 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

    "THE DOCTOR WAS USING THE BIOPSY FOR CAUTERY AND ONE SIDE OF THE TIP BURNED AND CUTS OFF". 1216677-2020-00189-1 900-151 FISCHER CONE BIOP EX MED (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORT SUBMITTED BY CSI REP. INCIDENT DETAIL: THE DOCTOR WAS USING THE BIOPSY FOR CAUTERY AND ONE SIDE OF THE TIP BURNED AND CUTS OFF. REF (B)(4). FISCHER CONE BIOP EX MED 900-151 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905081 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 271073 00888937003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other