BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 18432401 · Received January 2, 2024

    Report

    Report Number
    2955842-2023-21871
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 13, 2023
    Report Date
    December 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. SYNCH ACTIVATION WAS BEING PERFORMED. THE SURGEON EXPERIENCED ENERGY BEING APPLIED AND THE GENERATOR WAS ACTIVATED WITH ITS NORMAL TONES BUT NO CHANGES TO THE TISSUE WAS NOTED. THE INSTRUMENT DID NOT WORK AT ALL DURING THE PROCEDURE. NO ERRORS OCCURRED WHEN THE SYNCHROSEAL ISSUE OCCURRED. THERE WERE CONTINUOUS TONES WHILE THE PEDAL WAS BEING PRESSED DURING THE SEALING SEQUENCE. NO FAST AUDIBLE TONES WERE HEARD SUGGESTING SEALING OR SYNC MODE CYCLE WAS COMPLETED SUCCESSFULLY. NO TISSUE EFFECT WAS OBSERVED DURING THE SEALING/SYNC CYCLE. TISSUE WAS NEVER SUCCESSFULLY SEALED THEREFORE TISSUE WAS NOT CUT. TARGET TISSUE WAS OMENTUM. THE TARGET TISSUE WAS UNDER MINIMAL TENSION DURING THE SEALING/CUTTING PROCESS. VESSEL CALCIFICATION WAS NOT VISIBLE. IT IS UNKNOWN IF THE TISSUE WAS EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THE JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED ISSUE WAS NOTED. THE JAWS WERE NOT IMMERSED IN A LIQUID OR CONTAMINATED BY CARBON TISSUE PRIOR TO OR DURING THE SEALING CYCLE. NO ADDITIONAL BLEEDING WAS EXPERIENCED BY THE PATIENT. THE SURGEON DOES NOT KNOW WHAT CAUSED THE SYNCHROSEAL ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS NOT ACTIVATING, COULD HEAR THE NOISE BUT DID NOT SEAL OR DO THE DISSECTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491931 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L10231005 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES