BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ENERGY

    MDR report key: 12351958 · Received August 21, 2021

    Report

    Report Number
    2955842-2021-10966
    Event Type
    Injury
    Date Received
    August 21, 2021
    Date of Event
    July 26, 2021
    Report Date
    July 27, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THE DISTAL WASHER DISLODGED. THE DISTAL WASHER WAS RETURNED WITH THE INSTRUMENT. NO DAMAGE TO THE DISTAL PIN WAS OBSERVED. THE DISTAL WASHER EXHIBITED MECHANICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT SWIPE TESTS. THE INSTRUMENT WAS RETURNED WITH THE ENERGY CORD CUT. NO FAILURES FOUND DURING LOG REVIEW. THE INSTRUMENT WAS TRANSFERRED TO THE FAILURE ANALYSIS ENGINEER WHO CONFIRMED FA'S FINDINGS. THE PIVOT PIN WASHER WAS FOUND TO BE DISLODGED FROM THE INSTRUMENT. THE PIVOT PIN WASHER WAS FOUND TO BE CRACKED, SUGGESTING THE PRIMARY REASON FOR THE DISLODGED PIVOT PIN WAS A COLLISION. ADDITIONALLY, WHILE THE PIVOT PIN WAS NOTICEABLY SWAGED, THE SWAGE ITSELF APPEARED TO BE SLIGHTLY LOPSIDED, WHICH MAY HAVE ALLOWED THE PIVOT PIN WASHER TO DISLODGE WITH LESS FORCE. THE DISLODGED WASHER IS LIKELY DUE TO MISHANDLING MISUSE, HOWEVER THE LOPSIDED SWAGE IS DUE TO WORKMANSHIP ISSUE. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT (PART # 480440-05/ LOT # T90201105-0051) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK0873. THE ALLEGED EVENT OCCURRED ON THE 1ST USE OF THE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A PIECE OF PLASTIC FROM A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME, OR INJURY. HOWEVER, UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION, CONTRIBUTING TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF PLASTIC FROM A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR AT THE SITE ON 09-AUG-2021 AND OBTAINED THE FOLLOWING INFORMATION: BOTH THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED TO ISI. THEY RETRIEVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. SHE ESTIMATED THE INSTRUMENT WAS IN USE FOR 2 MINUTES BEFORE IT BROKE. NO POST-OPERATIVE TESTS WERE PERFORMED AND THERE HAVE BEEN NO REPORTS OF ANY COMPLICATIONS TO THE PATIENT POST-PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT JUST FINISHED SEALING AND CUTTING TISSUE WHEN A PIECE OF PLASTIC FELL OFF THE SYNCROSEAL INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR WITH ANY HARD OBJECT. THE ROBOTICS COORDINATOR DID NOT WANT TO SHARE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249096 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-05 T90201105 0051 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES.