BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 11567793 · Received March 25, 2021

    Report

    Report Number
    1216677-2021-00036
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 3, 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. DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM GEOTEC,INC, PACKAGED BY CSI IN OCTOBER 2020 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR 290763 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC RECORD-20-09-16-005 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. CORRECTIVE ACTIONS 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

    "WE HAVE RECEIVE A VIGILANCE ABOUT FISHER CONE BIOPSY EXCISOR FROM FRENCH HOSPITAL 4 FISHER CONE BIOPSY EXCISOR - MEDIUM ARE BROKEN DURING USER". 900-151 FISCHER CONE BIOP EX MED 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." FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469828 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 290763 00888937003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other