BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISCHER CONE BIOP EX MULT

    MDR report key: 7492559 · Received May 7, 2018

    Report

    Report Number
    1216677-2018-00021
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    May 4, 2018
    Report Date
    December 18, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K061651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4). INVESTIGATION: NO SAMPLE RETURNED. REVIEW DHR; ANALYSIS AND FINDINGS: IT HAS BEEN APPROXIMATELY 60 DAYS AND THE REPORTED SAMPLE HAS NOT BEEN RETURNED. THIS PRODUCT IS PURCHASED FROM A SUPPLIER AND IS POUCHED AND PACKAGED AT COOPERSURGICAL. A REVIEW OF THE DHR (213432, 209050) DID NOT SHOW ANY ABNORMALITIES. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO OTHER COMPLAINTS. THE REPORTED EVENT CANNOT BE VERIFIED OR CONFIRMED AS THE AFFECTED SAMPLE WAS NOT RETURNED FOR VISUAL EVALUATION. DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT IS INDETERMINABLE, HOWEVER, IT IS SUSPECTED THE DEVICE MAY HAVE BEEN USED OUTSIDE ITS RECOMMENDED POWER RANGE CAUSING THE WIRE TO BREAK. PREVIOUS ENGINEERING TESTING AT CSI COULD NOT DUPLICATE REPORTED FAILURES WHEN THE DEVICE WAS USED IN ACCORDANCE TO INSTRUCTIONS FOR USE. CORRECTIVE ACTIONS: CORRECTION AND/OR CORRECTIVE ACTION; CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME AS THE ROOT CAUSE IS INDETERMINABLE. WILL CONTINUE TO MONITOR AND TREND FOR THIS ISSUE. THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED SHOULD THE SAMPLE BE RETURNED. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    "WHILE DOING A LEEP TODAY WITH A FISCHER EXCISOR, DR. JENG HAD A PROBLEM WITH IT. THE EXCISOR BROKE DURING THE PROCEDURE. IT APPEARS THAT WE RECIVERED ALL THE PIECES AND THE PATIENT WAS OK." "SMALL EXCISOR WAS CONNECTED TO A COVIDIAN VALLEYLAB BOVIE PENCIL, PLUGGED IN TO A COVIDIAN FORCE TRIAD GENERATOR THAT WAS SET TO CUT 50 , COAG 50. AS SOON AS THE MD STARTED EXCISING THE SPECIMEN THERE WAS A POP, A SMALL SPARK , AND THEN THE EXCISOR CUTTING WIRE BROKE APART. ALL PIECES WERE RECOVERED. PATIENT AND MD APPEARED UNHARMED. " REF (B)(4).

    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

    "WHILE DOING A LEEP TODAY WITH A FISCHER EXCISOR, DR JENG HAD A PROBLEM WITH IT. THE EXCISOR BROKE DURING THE PROCEDURE. IT APPEARS THAT WE RECOVERED ALL THE PIECES AND THE PATIENT WAS OK. " "SMALL EXCISOR WAS CONNECTED TO A COVIDIEN VALLEYLAB BOVIE PENCIL, PLUGGED IN TO A COVIDIEN FORCE TRIAD GENERATOR THAT WAS SET TO CUT 50, COAG 50. AS SOON AS THE MD STARTED EXCISING THE SPECIMEN THERE WAS A POP, A SMALL SPARK, AND THEN THE EXCISOR CUTTING WIRE BROKE APART. ALL PIECES WERE RECOVERED. PATIENT AND MD APPEARED UNHARMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332148 FISCHER CONE BIOP EX MULT FISCHER CONE BIOP EX MULT HGI COOPERSURGICAL, INC. 900-156 213432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention