BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX SM

    MDR report key: 13861723 · Received March 23, 2022

    Report

    Report Number
    1216677-2022-00092
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    January 10, 2022
    Report Date
    June 8, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-NO SAMPLE RETURNED, X-REVIEW DHR. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/19/2020 UNDER WO # (B)(4) AND SHIPPED ON 01/25/2021. MANUFACTURING RECORD REVIEW: DHR-290748 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC-15006-01 LOT NUMBER MO080720-02 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 SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION / FUNCTIONAL EVALUATION:: 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: THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. DEFINITIVE ROOT CAUSE IS INDETERMINABLE. HOWEVER, PREVIOUS TESTING PERFORMED IN MARCH 2019 ATTEMPTING TO REPLICATE REPORTED EVENTS OF THE WIRE "BURNING" OR "SNAPPING" INDICATED THE PRODUCT PERFORMED AS INTENDED. CORRECTION AND/OR CORRECTIVE ACTION / PREVENTATIVE ACTION ACTIVITY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    PER MEDWATCH_UF_IMPORTER REPORT NO. (B)(4)- FISCHER CONE BIOPSY USED DURING PROCEDURE BROKE AND ANOTHER ONE WAS OPENED AND THAT ALSO BROKE DURING THE CASE. THE WIRES BREAKS, THIS IS THE THIRD TIME. FISCHER CONE BIOP EX MED 900-151. (B)(4).

    Description of Event or Problem · 0

    PER MEDWATCH_UF_IMPORTER REPORT NO. (B)(4) FISCHER CONE BIOPSY USED DURING PROCEDURE BROKEAND ANOTHER ONE WAS OPENED AND THAT ALSO BROKE DURING THE CASE. THE WIRES BREAKS, THIS IS THE THIRD TIME. 1216677-2022-00092 FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13047 FISCHER CONE BIOP EX SM FISCHER CONE BIOP EX SM HGI COOPERSURGICAL, INC. 900-151 290748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other