BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 11544053 · Received March 22, 2021

    Report

    Report Number
    1216677-2021-00035
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 1, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937003710
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO SAMPLE RETURNED REVIEW DHR ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM GEOTEC,INC, PACKAGED BY CSI IN MARCH 2020 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR 287598 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC RECORD-20-03-21-022 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 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 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 ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    BROKE DURING USE. 1216677-2021-00035-1 FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL COMPLAINT IN REF. TO E-COMPLAINT (B)(4). REPORT STATED "WE HAVE RECEIVE A VIGILANCE ABOUT FISHER CONE BIOPSY EXCISOR FROM FRENCH HOSPITAL 4 FISHER CONE BIOPSY EXCISOR: MEDIUM ARE BROKEN DURING USE. THE HOSPITAL KEPT THE DEFECTIVE PRODUCTS FOR ANALYSIS. 03.02.2021-UPDATED WITH COMPLAINT FORM PER FOLLOW-UP RESPONSE: PATIENT HAS NO PROBLEM. 1216677-2021-00035 FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445140 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 287598 00888937003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other