BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 8649581 · Received May 29, 2019

    Report

    Report Number
    1216677-2019-00095
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 29, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF E-COMPLAINT-(B)(4) *INVESTIGATION X-INITIATED MANUFACTURER'S INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM GEO TECH, PACKAGED BY CSI ON 03/27/2017 UNDER WORK ORDER 219142. MANUFACTURING RECORD REVIEW DHR-900-151-219142 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 DID SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT WAS RECEIVED, VERIFIED, AND CONFIRMED FOR THE REPORTED EVENT. VISUAL EVALUATION VISUAL EXAMINATION OF THE COMPLAINT PRODUCT WAS PERFORMED AND REPORTED COMPLAINT EVENT WAS CONFIRMED. 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 MARCH OF 2019 AND RESULTED IN THE SAME MANNER. SEE ATTACHED COPIES OF TESTING REPORTS. *CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    "WIRE BROKE DURING LEEP ... DELAYED PROCEDURE BY 15 MINUTES TO MINIMIZE BLEEDING, AT WHICH TIME AN ADDITIONAL LOOP SIZE LARGE WAS USED AND WORKED FINE, THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL ISSUES . PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL ATTENTION /TREATMENT AND WAS FINE AT THE COMPLETION OF PROCEDURE." REF (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "WIRE BROKE DURING LEEP ... DELAYED PROCEDURE BY 15 MINUTES TO MINIMIZE BLEEDING, AT WHICH TIME AN ADDITIONAL LOOP SIZE LARGE WAS USED AND WORKED FINE, THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL ISSUES . PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL ATTENTION /TREATMENT AND WAS FINE AT THE COMPLETION OF PROCEDURE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445236 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 219142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other