BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 12979174 · Received December 10, 2021

    Report

    Report Number
    2955842-2021-11715
    Event Type
    Injury
    Date Received
    December 10, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 15, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112427
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN RELATION TO THE REPORTED EVENT, ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5105430 WITH THE FOLLOWING EVENT DESCRIPTION: "ROBOTIC CASE IN PROGRESS WITH 45MM STAPLER. STAPLER CLAMPED DOWN ON TISSUE AND WAS NOT ABLE TO DISCONNECT. SURGEON PRESSED EMERGENCY RELEASE BUTTON ON CONSOLE AND ASSIST USED EMERGENCY SCREW TO UNLOCK STAPLER FROM PATIENT WITH NO SUCCESS. DAVINCI REP CALLED AND CAME IN TO ASSIST. SURGEON WAS ABLE TO REMOVE STAPLER AND PROCEED WITH SURGERY. INSTRUMENT MALFUNCTION. WORKING WITH INTUIT REMOTELY. VENDOR WAS ABLE TO WORK WITH PHYSICIAN TO SUCCESSFULLY DISENGAGE STAPLER FROM BOWEL. INSTRUMENT WAS LABELED AND REMOVED FROM SERVICE. VENDOR HAS SUBMITTED REQUEST FOR IR. A (B)(6) YEAR OLD MALE WITH QUADRIPLEGIA SUSTAIN AFTER DIVING INTO 3 FT OF WATER. HE UNDERWENT C4-5/6 ACDF WITH PLATING ON (B)(6) 2021. HIS HOSPITAL COURSE WAS COMPLICATED BY BRADYCARDIA WITH ASYSTOLE, NEUROGENIC SHOCK AND MUCUS PLUGGING. LAST COLONOSCOPY ~ 3 YEARS AGO, HE DOES HAVE A HISTORY OF COLON POLYPS, NO KNOWN FAMILY HISTORY OF COLON CANCER. HISTORY OF UMBILICAL HERNIA REPAIR WITH MESH MANY YEARS AGO. HE IS NOW AT A FACILITY FOR REHABILITATION. WE HAVE BEEN CONSULTED FOR COLOSTOMY TO HELP EASE CARE. HE WISHES TO HAVE A SPT PLACED AS A COMBINED PROCEDURE WITH UROLOGY. NKDA TOBACCO USE - (B)(6). FDA SAFETY REPORT ID # (B)(4)." INTUITIVE SURGICAL, INC. (ISI) PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE ENDOWRIST STAPLER 45 INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TO BE PERFORMED, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE HAS NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE STAPLER 45 INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE STAPLER 45 WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK1114. THE INSTRUMENT HAD 6 USES REMAINING. LOGS INDICATED THE ESTOP BUTTON WAS USED ON THE STAPLER INSTRUMENT WHEN THE REPORTED ISSUE OCCURRED. A REVIEW OF THE INSTRUMENT LOG REVIEW FOR THE ENDOWRIST STAPLER 45 INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: LOGS SHOW THAT PN 470298-14, LOT T10201112-0050 WAS INSTALLED ONCE WITH A GREEN RELOAD. THE INSTRUMENT COMPLETED A CLAMP, THEN AS THE INSTRUMENT WAS SHIFTING INTO THE FIRE STATE, THERE WAS A SHIFTING FAILURE THAT OCCURRED. ERROR 22030 IN THE LOGS WAS FOR THE SHIFTING FAILURE FROM ROLL INTO FIRE STATE. SHIFTING FAILURE RESULTS IN A USER FACING MESSAGE INDICATING THE STAPLER RELEASE KIT (SRK) MAY BE REQUIRED. LOGS SHOW THAT E-STOP WAS PRESSED AND THERE WERE 3 SEPARATE INSTANCES WHERE THE SYSTEM DETECTED SRK WAS USED ON THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOWRIST STAPLER 45 FAILED TO UNCLAMP AND RELEASE FROM TISSUE WITH NO EVIDENCE OR CLAIM OF MISHANDLING OR MISUSE. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE STAPLER FAILS TO UNCLAMP FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE UNCLAMPING EVENT TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE THE SURGEON WAS UNABLE TO OPEN THE ENDOWRIST STAPLER 45 INSTRUMENT JAWS. THE REPORTER EXPLAINED THE STAPLER WAS CLAMPED ON TISSUE AND THE RELEASE KEY WAS NOT SUCCESSFUL IN RELEASING THE TISSUE. TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE SITE PRESSED THE ESTOP BEFORE ATTEMPTING TO RELEASE THE INSTRUMENT. TSE RECOMMENDED THE SITE TO RETRY THE STEPS OUTLINED IN THE RELEASE KEY INSTRUCTIONS, BUT THE SITE REMAINED UNSUCCESSFUL. TSE STATED AT THIS TIME THE SITE WILL HAVE TO USE ALTERNATE CLINICAL METHODS TO REMOVE THE STAPLER. TSE INQUIRED IF FURTHER SUPPORT TO STAY ON THE LINE UNTIL THE INSTRUMENT WAS REMOVED, BUT THE REPORTER HAD TO DISCONNECT THE CALL. TSE REVIEWED LIVE LOGS AND NOTED ERROR 22030 POINTING TO STAPLER FAILURE ISSUE. THE SITE PROCEEDED WITH THE CASE AS PLANNED AND THERE WAS NO REPORT OF PATIENT INJURY. FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CUSTOMER REMOVED THE INSTRUMENT AND WILL RETURN THE STAPLER INSTRUMENT FOR FAILURE ANALYSIS. INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SALES ASSOCIATE (CSA) WHO WAS PRESENT FOR THE CASE AND OBTAINED THE FOLLOWING INFORMATION: THE STAPLER INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS PREPARING TO TRANSECT ACROSS THE BOWEL WHEN THE REPORTED ISSUE OCCURRED. WHEN THE SURGEON CLAMPED AND DECIDED TO UNCLAMP THE STAPLER; THE INSTRUMENT WOULD NOT OPEN. THE SITE USED THE STAPLER RELEASE KIT (SRK), BUT THE INSTRUMENT DID NOT OPEN TO THE EXTENT THE OPERATING ROOM (OR) TEAM WAS USED TO WHEN USING THE SRK. AT THE TIME A GREEN LOAD WAS USED AND THE STAPLER INSTRUMENT CLAMPED NORMALLY, BUT WOULD NOT OPEN AFTER INITIAL CLAMPING. THE REPORTED ISSUE OCCURRED DURING THE STAPLER FIRST FIRE AND WAS USED APPROXIMATELY UNDER 5 MINUTES. THE SITE ENCOUNTERED NO ERROR MESSAGE, NO OBSTRUCTIONS DURING USE, NO BUTTRESS MATERIAL WAS USED, NO MALFORMED STAPLES NOR DID THE SURGEON EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE RELOAD ON THE STAPLER INSTRUMENT. THE BOWEL WAS THE TARGET TISSUE AND THE SURGEON EXPANDED INCISION FOR LEFT HAND, ADDED 12 PORT AND ENTERED IN A NEW STAPLER. PRIOR TO FIRING THE NEW STAPLER, THE BOWEL (I.E. TARGET TISSUE) SLID OUT OUT OF THE STAPLER INITIALLY USED. PER THE CSA, THE INSTRUMENT JAWS WERE STUCK ON THE TARGET TISSUE AND THE SRK DID NOT APPEAR TO OPEN THE JAWS FULLY. THE HOLES ON THE STAPLER FOR THE SRK TURNED AS NORMAL, HOWEVER THE JAWS WOULD NOT OPEN FULLY. THE 3RD HOLE APPEARED TO KEEP TURNING, BUT COULD HAVE BEEN A USER ERROR OF THE OR ASSISTANT. THE CSA EXPLAINED THERE WERE NO ADVERSE EFFECTS TO THE GRASPED TISSUE AND NO UNEXPECTED TISSUE REMOVAL. THERE WERE NO UNEXPECTED BLEEDING WHEN THE SRK WAS USED ON THE STAPLER 45 INSTRUMENT. THE SITE WILL RETURN THE STAPLER INSTRUMENT AND THE RELOAD WILL NOT BE RETURNED FOR ISI EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876527 ENDOWRIST STAPLER 45 NAY INTUITIVE SURGICAL, INC 470298-14 T10201112 0050 00886874112427

    Patients

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