BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX M/EX

    MDR report key: 9769297 · Received February 28, 2020

    Report

    Report Number
    1216677-2020-00059
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 23, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937003734
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION REVIEW DHR INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE 15006-04 FISHER CONE ASSEMBLY WAS PURCHASED FROM GEOTEC, INC. AS AN OEM FINISHED PRODUCT, RECEIVED AT CSI 8/2/2019, ISSUED TO WORK ORDER (B)(4) AND COMPLETED 8/15/2019. 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 WAS PERFORMED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE PRODUCT TWO-YEAR HISTORY INDICATED THAT PREVIOUS COMPLAINTS RELATED TO THE DESCRIPTION OF THE REPORTED EVENT WERE REPORTED. THE REPORTED EVENT WILL BE MONITORED FOR POSSIBLE FUTURE REPORTED EVENT TRENDING. PRODUCT RECEIPT THE SAMPLE WAS VERIFIED FOR THE REPORTED EVENT AND CONFIRMED IN THE WAY OF BURNT WIRE ON 7/21/2020. VISUAL EVALUATION THE SAMPLE WAS VERIFIED AND CONFIRMED FOR THE REPORTED EVENT. FUNCTIONAL EVALUATION FUNCTIONAL EVALUATION IS NOT APPLICABLE TO THIS COMPLAINT. 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 (B)(6) OF 2019 AND RESULTED IN THE SAME MANNER. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    WIRE BROKE DURING USE. 1216677-2020-00059-1 FISCHER CONE BIOP EX M EX 900-154 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORT MADE BY - (B)(6). END-USER STATED- WIRE BROKE DURING USE, EXPERIENCED OPERATOR. THIS HAS OCCURRED ON MULTIPLE OCCASIONS OVER THE LAST FEW MONTHS SEE PREVIOUS COMPLAINT MADE IN (B)(6) 2019 ( REF: JPC19/341), SAME PROBLEM DIFFERENT BATCH/LOT NUMBER." REF E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235659 FISCHER CONE BIOP EX M/EX FISCHER CONE BIOP EX M/EX HGI COOPERSURGICAL, INC. 900-154 264266 00888937003734

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other