BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX LG

    MDR report key: 7478257 · Received May 1, 2018

    Report

    Report Number
    1216677-2018-00019
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    March 31, 2018
    Report Date
    May 18, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGIAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT-2018-04-0000148. UPDATE 5/18/18: INVESTIGATION: THE REPORTED RESULT IN THE EVENT COULD NOT BE CONFIRMED AS THE ACTUAL SAMPLE WAS NOT RETURNED FOR INVESTIGATIVE ANALYSIS. HOWEVER, IF IN THE FUTURE THE SAMPLE MADE AVAILABLE, THE INVESTIGATION MAY BE REOPENED AND ADDRESSED AS NEEDED. REVIEW OF THE TWO-YEAR TRACKED COMPLAINT HISTORY DID NOT HAVE ANY DEFINITIVE TREND. PREVIOUS ENGINEERING TESTING IN TRYING TO DUPLICATE REPORTED EVENTS WERE NOT SUCCESSFUL IN PRODUCING THE FAILURES AS REPORTED WHEN RECOMMENDED POWER SETTINGS WERE USED. IT IS POSSIBLE THAT A FAULTY GENERATOR OR IMPROPER POWER OUTPUT THAT WAS CONTRA TO THE POWER SETTING COULD HAVE BEEN THE CAUSE FOR THE FAILURE. PROPER OUTPUT MONITORING OR OUTPUT VERIFICATION IS RECOMMENDED IN THE PRODUCT DEVICE DFU). REVIEW OF THE LOT DHR DID NOT REVEAL ANY ABNORMALITY.. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    MEDWATCH RECEIVED. UFI/IMPORTER REPORT# 4100070000-2018-8013. "DESCRIBE THE EVENT OR PROBLEM: WE WERE DOING A LEEP PROCEDURE AFTER PROCEDURE THE SURGICAL TECH TOLD ME THAT THE SURGEON TOLD HER THAT HE BROKE THE STRING IN THE FISCHER CONE BIOPSY EXCISOR. ITEM BROKE IN PATIENT BUT INSTRUMENT WITH STRING REMOVED IN ITS ENTIRETY. TEAM FOLLOWED POLICY TO ENSURE NO RETAINED SURGICAL ITEMS. PLANNED PROCEDURE COMPLETED WITHOUT COMPLICATION AND DISCHARGED HOME LATER THAT DAY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING);" 5/1/16: "THE SEX OF THE PATIENT IS ACTUALLY FEMALE. I HAVE CONTACTED MEDSUN FOR CORRECTION. ALSO, THE DEVICE IS NOT AVAILABLE FOR RETURN."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDWATCH RECEIVED. UF/IMPORTER REPORT# (B)(4). "DESCRIBE THE EVENT OR PROBLEM: WE WERE DOING A LEEP PROCEDURE AFTER PROCEDURE THE SURGICAL TECH TOLD ME THAT THE SURGEON TOLD HER THAT HE BROKE THE STRING IN THE FISCHER CONE BIOPSY EXCISOR. ITEM BROKE IN PATIENT BUT INSTRUMENT WITH STRING REMOVED IN ITS ENTIRETY. TEAM FOLLOWED POLICY TO ENSURE NO RETAINED SURGICAL ITEMS. PLANNED PROCEDURE COMPLETED WITHOUT COMPLICATION AND DISCHARGED HOME LATER THAT DAY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING);" (B)(6) 2016: "THE SEX OF THE PATIENT IS ACTUALLY FEMALE. I HAVE CONTACTED MEDSUN FOR CORRECTION. ALSO, THE DEVICE IS NOT AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318450 FISCHER CONE BIOP EX LG FISCHER CONE BIOP EX LG HGI COOPERSURGICAL, INC. 900-152 195015

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention