BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R2015 RADIUS LOOP

    MDR report key: 8116893 · Received November 29, 2018

    Report

    Report Number
    1216677-2018-00075
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    March 22, 2018
    Report Date
    December 27, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K905747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4). *INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED. *ANALYSIS AND FINDINGS THE REPORTED EVENT CANNOT BE PHYSICALLY VERIFIED AS THE DEVICE MENTIONED IN THE REPORTED EVENT WAS NOT RETURNED. HOWEVER, IF THE DEVICE IS LOCATED AND MADE AVAILABLE IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. INVENTORIES OF THE AFFECTED LOT WERE DEPLETED AND NOT AVAILABLE FOR FURTHER VERIFICATION AT FG WAREHOUSE. THIS DEVICE IS OEM MANUFACTURED FOR CSI, SENT FOR STERILIZATION AND DISTRIBUTED IT FROM FG WAREHOUSE TRUMBULL. DHR REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS REPORTED AS "UNKNOWN". A REVIEW OF THE TWO-YEAR PRODUCT COMPLAINT HISTORY ONE OTHER COMPLAINT RELATED TO THE REPORTED EVENT, IT SHOULD BE NOTED THAT BOTH REPORTED EVENTS WERE FROM THE ACCOUNT. ALTHOUGH THE ROOT CAUSE IS INDETERMINABLE IT'S POSSIBLE THAT THAT THE DEVICE MAY HAVE BEEN USED IN CONTRARY INDICATED MANNER IN RELATION TO PROPER SIZE AND OR POWER OUTPUT. *CORRECTION AND/OR CORRECTIVE ACTION CORRECTIVE IS NOT APPLICABLE DUE TO THE AFFECTED DEVICE NOT BEING AVAILABLE FOR INVESTIGATIVE ANALYSIS AT THE TIME OF THIS INVESTIGATION, MONITORING VIA COMPLAINT/ PRODUCT SURVEILLANCE WILL CONTINUE IN ORDER TO IDENTIFY ANY POSSIBLE TREND. *WAS THE COMPLAINT CONFIRMED? NO. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    "LOOP DID NOT CUT JUST CHARRED EDGE OF TISSUE. HAD TO CHANGE LOOPS." "MD FRUSTRATED DUE TO CHAR OF TISSUE WHEN MARGINS ARE NEEDED!" REF (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "LOOP DID NOT CUT JUST CHARRED EDGE OF TISSUE. HAD TO CHANGE LOOPS." "MD FRUSTRATED DUE TO CHAR OF TISSUE WHEN MARGINS ARE NEEDED !" (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958093 R2015 RADIUS LOOP R2015 RADIUS LOOP HGI COOPERSURGICAL, INC. R2015 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other