BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MED

    MDR report key: 10253486 · Received July 9, 2020

    Report

    Report Number
    1216677-2020-00143
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 18, 2020
    Report Date
    February 1, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937003710
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION: NO SAMPLE RETURNED: REVIEW DHR: THE COMPLAINT PRODUCT WAS PURCHASED FROM GEOTEC AND PACKAGED BY CSI ON 01/05/18 UNDER WORK ORDER 232533. MANUFACTURING RECORD REVIEW: DHR-900-151- 232533 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 DID SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT IS NOT AVAILABLE. IF THE PRODUCT BECOMES AVAILABLE 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 IS NOT AVAILABLE. IF THE PRODUCT BECOMES AVAILABLE 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: COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COMPLAINT COULD NOT BE CONFIRMED, NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    CUSTOMER STATED: "THE ELECTRODE TIP MELTED WHEN IN USE FOR A LEEP PROCEDURE". 1216677-2020-00143-1 900-151 FISCHER CONE BIOP EX MED (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. REF E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    PER REPORT LEEP PROCEDURE. (B)(6) 2020- UPDATE_"LEEP CONE BIOPSY". REF E-COMPLAINT-(B)(4). FISCHER CONE BIOP EX MED 900-151 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719087 FISCHER CONE BIOP EX MED FISCHER CONE BIOP EX MED HGI COOPERSURGICAL, INC. 900-151 271093 00888937003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other