BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 10086498 · Received May 26, 2020

    Report

    Report Number
    1216677-2020-00122
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    March 13, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION, REVIEW DHR, INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM GEOTEC ON 10/30/19. MANUFACTURING RECORD REVIEW: DHR-900-151 - 271093 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC INSPECTION REPORT (11/4/2019) OF TOP ASSEMBLY PART NUMBER 15006-02 FOR LOTS MO100719-01 AND MO100719-02 FROM GEO TEC WERE 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 ATTACHED 2-YEAR COMPLAINT HISTORY INDICATED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT RETURNED TO COOPERSURGICAL 5/27/2020. VISUAL EVALUATION: VISUAL EVALUATION OF THE COMPLAINT UNIT WAS PERFORMED, AND THE REPORTED EVENT WAS CONFIRMED AS REPORTED. FUNCTIONAL EVALUATION : NOT APPLICABLE FOR THE STATE OF THE RETURNED DEVICE. 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 TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. NO FURTHER TRAINING REQUIRED AT THIS TIME; COMPLAINT WILL BE MONITORED FOR TRENDING. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: "DEFECTIVE/MELTED END OF ELECTRODE". 900-151 FISCHER CONE BIOP EX MED (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. (B)(4).

    Description of Event or Problem · 1

    REPORT STATED "DEFECTIVE/MELTED END OF ELECTRODE". (B)(4). FISCHER CONE BIOP EX MED 900-151.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553526 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 271093 00888937003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other