BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 15649745 · Received October 21, 2022

    Report

    Report Number
    1063481-2022-00021
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    July 29, 2022
    Report Date
    November 2, 2022
    Manufacturer
    ARTIVION, INC.
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    DARK/BLACK PARTICULATE WAS PRESENT AT THE NOSE CONE PIECE WITH ASHES, POSSIBLY FROM BURNED MATERIAL. THE DEVICE WAS TAKEN APART TO STUDY THE FIBER COMPONENT/INTERIOR OF THE DEVICE. THE FIBERS WERE EXPOSED WITH A CHARRED PLASTIC SLEEVE. THE CONCLUSION OF THIS EVALUATION REVEALED THE FIBERS ON DEFECTIVE UNIT WERE MOST LIKELY BROKEN PRIOR TO USE AND THEN SHEARED OFF DURING SURGERY. THE CONTINUITY TEST PERFORMED AS AN IN-PROCESS INSPECTION PASSED. THE MANUFACTURING RECORDS FOR THE HP-SG3 (LOT TA-04164, SN 13) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. NO DEVIATIONS WERE NOTED. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "TMR HP WAS USED IN A CABG CASE. WHILE BEING USED THE FIBER BROKE INTO 2 PIECES AND HAD TO BE REMOVED. THERE WAS NO ADVERSE EVENT TO THE PATIENT."

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "TMR HP WAS USED IN A CABG CASE. WHILE BEING USED THE FIBER BROKE INTO 2 PIECES AND HAD TO BE REMOVED. THERE WAS NO ADVERSE EVENT TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927742 SOLOGRIP III HANDPIECE SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION MNO ARTIVION, INC. HP-SG3 TA-04164

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female