BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 12643533 · Received October 15, 2021

    Report

    Report Number
    2955842-2021-11311
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 22, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE DETAILS OF THE MEDICAL INTERVENTION DONE IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/ INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. ISI HAS REQUESTED FOR RETURN OF THE VSE INSTRUMENT. HOWEVER, AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE VSE INSTRUMENT INVOLVED IN THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE VSE IS INTENDED FOR GRASPING AND BLUNT DISSECTION OF TISSUE AND FOR BIPOLAR COAGULATION AND MECHANICAL TRANSECTION OF VESSELS UP TO 7 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. WHEN FUNCTIONING PROPERLY, THE INSTRUMENT HAS BOTH VISUAL (TISSUE EFFECT) AND AUDIO (TONES FROM THE GENERATOR) CUES THAT PROVIDE FEEDBACK TO THE USER THAT IT IS OPERATING AS INTENDED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: SMALL GRASPING RETRACTOR, AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. THE SYSTEM LOGS WERE REVIEWED BY THE ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE) TEAM AND THE FOLLOWING INFORMATION WAS OBTAINED: WITH VSE INSTRUMENT (B)(4), IN THE DSP LOGS, THERE ARE 2 FAILED CUT EVENTS, ONE AT THE BEGINNING OF INSTRUMENT USE AND ONE JUST BEFORE THE BACKUP INSTRUMENT WAS INSTALLED. WITH THE FIRST FAILED CUT, THE BLADE DID NOT JAM. WITH THE SECOND FAILED CUT, THE BLADE JAMMED AND THE INSTRUMENT RAN THROUGH THE RECOVERY SEQUENCE. THE LOG MESSAGES SUGGEST THE INSTRUMENT WAS ABLE TO RECOVER THE BLADE BACK TO THE GARAGE, BUT THE USER SWAPPED TO THE BACKUP INSTRUMENT. ADDITIONALLY, THE DSP LOGS RECORDED 2 JAW ANGLE OPEN EVENTS, WHICH INDICATE THE JAWS ARE TOO FAR OPEN TO ALLOW FOR CUTTING (TISSUE TOO THICK, TOO MUCH TISSUE BETWEEN THE JAWS, ETC). THE SECOND FAILED CUT (WHERE THE BLADE JAMMED) WAS PRECEDED BY A JAW ANGLE OPEN EVENT AS WELL, SUGGESTING THE USER MAY HAVE BEEN TRYING TO CUT THROUGH TISSUE THAT WAS TOO THICK OR WITH TOO MUCH TISSUE BETWEEN THE JAWS. IN THE E-100 LOGS, THERE ARE 6 RECORDED HIGH INITIAL STARTING IMPEDANCE MESSAGES WITH THE FIRST INSTRUMENT USED. THESE MESSAGES INDICATE THE IMPEDANCE OF THE TISSUE BETWEEN THE JAWS WAS HIGHER THAN EXPECTED, USUALLY DUE TO QUANTITY, TISSUE TYPE, AMOUNT OF FLUID PRESENT, ETC. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE VSE INSTRUMENT DID NOT SUFFICIENTLY COMPLETE A SEAL EVEN THOUGH AUDIBLE BEEPS FROM THE GENERATOR PROVIDED A SIGNAL THAT INDICATED THAT THE SEAL WAS COMPLETE. THE GENERATOR USED WITH THE VSE INSTRUMENT AND DA VINCI SYSTEM IS DESIGNED TO PROVIDE A SUCCESSFUL CONFIRMATION SIGNAL TO INDICATE SEAL COMPLETION. DEFICIENCIES IN SEALING MAY LEAD TO INADEQUATE HEMOSTASIS. THE PATIENT SUSTAINED BLEEDING UP TO 200 ML DUE TO THE INSUFFICIENT SEALING. HOWEVER, IT IS NOT EVIDENT WHAT MEDICAL INTERVENTION WAS TAKEN TO STOP THE BLEEDING. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, DURING SEALING OF THE INFERIOR MESENTERY ARTERY (IMA) WITH THE VESSEL SEALER EXTEND (VSE) INSTRUMENT, THE SURGEON RECEIVED A ¿BLADE EXPOSED¿ ERROR. WHEN THE VSE INSTRUMENT WAS UNCLAMPED, THERE WAS A LARGE AMOUNT OF BLEEDING, UP TO 200 ML. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO SPOKE WITH THE SURGEON, AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE OCCURRED MIDWAY INTO THE PROCEDURE. THE VSE WAS WORKING FINE INITIALLY. THE GENERATOR PRODUCED THE APPROPRIATE TONES BUT DURING THE CUTTING PHASE, AN ERROR MESSAGE STATING, "BLADE EXPOSED," WAS OBTAINED. THERE WAS HEAVY BLEEDING WHEN THE SURGEON UNCLAMPED THE VSE INSTRUMENT. THE SURGEON USED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO CLAMP THE BLEEDING VESSEL, BUT SHE WAS UNSURE HOW THE BLEEDING WAS EVENTUALLY MANAGED. A BACKUP VSE WAS USED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE CSR IS NOT AWARE OF ANY TISSUE FACTORS THAT WOULD HAVE AFFECTED SEALING, OR WHETHER THE PATIENT WAS TRANSFUSED WITH BLOOD, OR WHETHER THERE WAS A PROLONGED HOSPITALIZATION OR ICU STAY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION DIRECTLY FROM THE SITE. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536243 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L91210614-0330 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1