BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 6984124 · Received October 27, 2017

    Report

    Report Number
    1063481-2017-00037
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 2, 2017
    Report Date
    April 3, 2018
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED HANDPIECE WAS SENT TO [CONTRACT MANUFACTURER] FOR AN ADDITIONAL EVALUATION. THE UNIT WAS REVIEWED BY THE PRODUCTION LEAD. THE THUMB LEVER MOVED EASILY WITH MINIMAL RESISTANCE. IT WAS NOTED THAT THIS MAY BE A RESULT OF THE UNIT BEING DISASSEMBLED AND REVIEWED PRIOR TO RECEIPT AT [CONTRACT MANUFACTURER]. [CONTRACT MANUFACTURER] WAS UNABLE TO REPLICATE THE COMPLAINT CONDITION. A REVIEW OF PRODUCTION DOCUMENTS FOR (B)(4) AND ALL APPLICABLE TESTING PROCEDURE WAS PERFORMED. ALL UNITS PASSED ALL APPLICABLE INSPECTIONS AND TESTS. [CONTRACT MANUFACTURER] WAS UNABLE TO REPLICATE THE CONDITION HOWEVER THEY HAVE ADDRESSED THE COMPLAINT WITH ALL MANUFACTURING PERSONNEL SO THAT THEY ARE AWARE AND WILL LOOK FOR THE CONDITION IN FURTHER BUILDS. 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 1

    A SAMPLE EVALUATION WAS PERFORMED FOR THE RETURNED HAND PIECE, LOT NUMBER TA ¿ 04102, SERIAL NUMBER (B)(4). IT WAS NOTED THE THUMB SLIDE ON THE HAND PIECE SEEMED TO BE CATCHING ON SOMETHING INTERNAL, REQUIRING MORE PRESSURE TO ADVANCE THE FIBER. THE HAND PIECE WAS TAKEN APART TO LOOK INTERNALLY. IT WAS NOTED THAT EVERYTHING LOOKED TO BE ASSEMBLED PROPERLY. AFTER FURTHER EXAMINATION, IT WAS NOTED THAT THE THERE IS A MISALIGNMENT BETWEEN THE FIBER SUPPORT STAINLESS STEEL CUBE AND THE WHITE PEBAX SLEEVE, CREATING RESISTANCE WHEN ADVANCED. THE TUBING ALSO LOOKED TO BE CUT AT AN ANGLE RATHER THAN SQUARE WHICH MAY HAVE CONTRIBUTED THE REPORTED EVENT. THE MANUFACTURING RECORDS FOR THE HP-SG3, TA-04102-82, 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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.

    Additional Manufacturer Narrative · 1

    A SAMPLE EVALUATION WAS PERFORMED FOR THE RETURNED HAND PIECE, LOT NUMBER TA ¿ 04102, SERIAL (B)(4). IT WAS NOTED THE THUMB SLIDE ON THE HAND PIECE SEEMED TO BE CATCHING ON SOMETHING INTERNAL, REQUIRING MORE PRESSURE TO ADVANCE THE FIBER. THE HAND PIECE WAS TAKEN APART TO LOOK INTERNALLY. IT WAS NOTED THAT EVERYTHING LOOKED TO BE ASSEMBLED PROPERLY. AFTER FURTHER EXAMINATION, IT WAS NOTED THAT THE THERE IS A MISALIGNMENT BETWEEN THE FIBER SUPPORT STAINLESS STEEL CUBE AND THE WHITE PEBAX SLEEVE, CREATING RESISTANCE WHEN ADVANCED. THE TUBING LOOKS TO BE CUT AT AN ANGLE RATHER THAN SQUARE. THE MANUFACTURING RECORDS FOR THE HP-SG3, TA-04102-82, 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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PER THE NOTIFICATION SENT BY THE REP "HP [HAND PIECE] WAS USED AND SURGEON COMPLAINED THAT THE THUMB LEVER WAS VERY STIFF AND HARD TO ADVANCE. HP WAS USED ON THE CASE AND THERE WAS NO IMPACT TO THE PATIENT. HP FIBER WAS CUT AT THE END OF THE CASE AFTER USE. IT WAS TANGLED IN SOME OF THE EQUIPMENT ON THE SURGICAL FIELD. NO OTHER INFORMATION PROVIDED."

    Description of Event or Problem · 1

    PER THE NOTIFICATION SENT BY THE REP "HP [HAND PIECE] WAS USED AND SURGEON COMPLAINED THAT THE THUMB LEVER WAS VERY STIFF AND HARD TO ADVANCE. HP WAS USED ON THE CASE AND THERE WAS NO IMPACT TO THE PATIENT. HP FIBER WAS CUT AT THE END OF THE CASE AFTER USE..IT WAS TANGLED IN SOME OF THE EQUIPMENT ON THE SURGICAL FIELD. NO OTHER INFORMATION PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763854 SOLOGRIP III HANDPIECE SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION MNO CRYOLIFE, INC. HP-SG3 TA-04102

    Patients

    Seq Age Sex Outcome Treatment
    1