BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    -FISCHER CONE BIOP EX LG

    MDR report key: 10710327 · Received October 21, 2020

    Report

    Report Number
    1216677-2020-00226
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 2, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937003727
    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 NO SAMPLE RETURNED REVIEW DHR DISTRIBUTION HISTORY: THE (B)(6) FISHER CONE ASSEMBLY WAS PURCHASED FROM GEOTEC, INC. AS AN OEM FINISHED PRODUCT, ISSUED TO WORK ORDER (B)(4) AS CSI PART NUMBER (B)(6). MANUFACTURING RECORD REVIEW: DHR-900-151 - (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. IF THE INCOMING INSPECTION RECORD SHOULD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. 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. 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. SEE ATTACHED COPIES OF TESTING REPORTS. CORRECTIVE ACTIONS: COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL SO THE COMPLAINT COULD NOT BE CONFIRMED. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTIONS NECESSARY. NO FURTHER TRAINING IS REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    "WIRE SNAPPING AT TIP OF INSTRUMENT (HAPPENED WITH X 6 ELECTRODES)". 1216677-2020-00226-1 900-152 FISCHER CONE BIOP EX LG (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    (B)(4). REPORT SUBMITTED BY DISTRIBUTOR ON BEHALF OF END-USER- INCIDENT -WIRE SNAPPING AT TIP OF INSTRUMENT (HAPPENED WITH X 6 ELECTRODES), ALSO HAPPENED DURING A CASE EARLIER THIS MONTH. I HAVE BEEN TOLD THAT THE PRODUCT WAS THROWN OUT. FISCHER CONE BIOP EX LG 900-152 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180432 -FISCHER CONE BIOP EX LG FISCHER CONE BIOP EX LG HGI COOPERSURGICAL, INC. 900-152 225656 00888937003727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other