BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX LG

    MDR report key: 16078232 · Received December 30, 2022

    Report

    Report Number
    1216677-2022-00333
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 13, 2022
    Report Date
    December 30, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    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 20-SEP-2021 UNDER WO # (B)(4) AND SHIPPED ON 24/NOV/2021. MANUFACTURING RECORD REVIEW: DHR-308500 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC-15006-03 LOT NUMBER MO072021-05 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 CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL 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. 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. THIS LOT NUMBER HAS BEEN DEPLETED FROM INVENTORY. 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. CORRECTIVE ACTIONS *CORRECTION AND/OR CORRECTIVE ACTION 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 . *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    DETAILS OF THE COMPLAINT: "THE MD MELTS DURING USE AND BREAKS." FISCHER CONE BIOP EX LG 900-152. (B)(4).

    Description of Event or Problem · 0

    DETAILS OF THE COMPLAINT: "THE MD MELTS DURING USE AND BREAKS" 1216677-2022-00333 FISCHER CONE BIOP EX LG 900-152 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825023 FISCHER CONE BIOP EX LG FISCHER CONE BIOP EX LG HGI COOPERSURGICAL, INC. 900-152 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other