MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number 480460-09

Device Problem Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the customer reported failure mode cannot be determined.The sureform 60 stapler instrument and reloads used during this event were discarded.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.A review of the system logs for the procedure date of (b)(6) 2022 has been performed and the following was observed: multiple error 22030's were identified indicating a sureform 60 stapler unclamp failure occurred with stapler instrument with serial number: (b)(4).Two error 256's occurred indicating the emergency stop button was pressed by the user; one time at surgeon side console #1 (ssc1) and the other press at ssc2.Several minutes after the emergency stop button was pressed the second time, multiple error 22020's were identified indicating a sureform 60 stapler failed to engage on usm3.An isi senior failure analysis engineer reviewed the stapler logs for the stapler instrument used in this event and the following information was provided: the logs show this stapler instrument was installed 8 times and fired 8 reloads (all white).The first 6 firings were completed per the logs with either 0 or 1 pauses for compression.Firing #7 resulted in a firing failure at 22% completion.Firing #8 resulted in a firing failure at 60% completion, then the subsequent unclamp failed at 42% completion.The user attempted to force unclamp which also failed at the same completion percentage.The logs confirm the two unclamp failures and also show the instrument was force expired following the first unclamp failure (as expected).The logs also show that the emergency stop button was pressed a couple of times after these unclamp failures.An isi field service engineer (fse) was dispatched to the customer site to further investigate reported instrument engagement issues on usm3.The fse replaced the usm to resolve the reported engagement issues.The system was tested and verified as ready for use.Isi has received the usm returned with this event, but failure analysis investigations are not yet complete.This event is being reported due to the following conclusion: during a da vinci-assisted sleeve gastrectomy procedure, the sureform 60 stapler instrument became stuck on the bowel.The surgeon used two cadiere forceps instruments to pull out the tissue stuck between the jaws of the stapler instrument.During this process, a small defect occurred on the stomach.The surgeon repaired the defect with sutures.Refer to medwatch report (mdr) with patient identifier #(b)(6) for additional information regarding the customer reported instrument engagement issues.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy procedure the sureform 60 stapler instrument became stuck on the bowel.The sureform 60 instrument was being used with a white sureform 60 stapler reload installed to form the sleeve.After firing the stapler reload, about 5mm¿s of tissue was left remaining that was about 2mm thick.The surgeon loaded another white stapler reload into the sureform 60 instrument to finish stapling this last portion of tissue.After approximately three seconds the firing mechanism engaged and the stapler instrument began to fire until it reached the 60mm mark.At that point, the stapler instrument paused for compression.An error message was received stating the tissue was too thick.The stapler instrument was disengaged via the foot pedal and the stapler instrument was opened.The surgeon reported: ¿the tissue was into the stapler at about the 20 mm mark on the stapler near the distal end and i don¿t understand why it felt that this tissue was too thick.¿ the surgeon used the same sureform 60 stapler instrument with another white stapler reload and introduced the tissue at the 40mm mark on the stapler instrument.The stapler instrument was clamped and left closed for about five to ten seconds before being fired.Then, the stapler instrument fired and stopped at the 39mm mark to compress.After a few seconds, another message was received stating the tissue was too thick and the surgeon used the foot pedal to unclamp the stapler instrument.At this time, the stapler instrument did not open.Another error message was received stating the stapler instrument would not open and the manual release knob (mrk) was required.The surgeon said he used the unclamp command via the foot pedal several more times with no change.The surgeon reported they followed the on-screen prompt to use the mrk.The surgeon reported hearing ¿cracking and crunching sounds but the stapler did not open.¿ the surgeon said they then called their intuitive surgical, inc.(isi) representative and were told they need to press the ¿red button¿ (emergency stop button) on the console prior to using the mrk.The emergency stop button was then pressed and the mrk was used again, but the stapler instrument did not open its jaws.The customer then called isi technical support who reportedly provided similar instructions but the stapler instrument still did not open.The isi technical support engineer (tse) walked the customer through pressing the emergency stop button and then rotating the mrk up to 40 times; the stapler jaws remained stuck.The tse asked if the surgeon was able to attempt opening the jaws with other instruments.The surgeon attempted this but was not successful.The customer removed the stapler instrument from the universal surgical manipulator (usm) but it did not release its jaws.The tse informed the customer they would have to utilize surgical intervention to remove the instrument.The call was ended.The surgeon reported removing the tissue stuck in the stapler instrument jaws by pulling it out of the jaws.A robotics coordinator from the site clarified that the surgeon used two cadiere forcep instruments to pull the stomach tissue out of the jaws of the sureform 60 stapler instrument.The surgeon reported that this event caused ¿a small defect at the end of the stomach.¿ the surgeon closed the small defect with sutures in several layers and reinforced the tissue with an omental patch.The surgeon reported this event did not cause any blood loss.The surgeon reported this event impacted the procedure outcome by significantly delaying the procedure and requiring extra maneuvers to correct the complications.The patient did well during their hospital stay and was discharged the next day without any complications.The patient has not reported any issues and has an upcoming follow-up appointment with the surgeon.The surgeon reported they have no concern of this event causing any long-term health complications with the patient, but stated this event could lead to a post-operative leak.The surgeon was asked what they believe caused this event and the surgeon stated that they are not sure.The surgeon said that one of the input discs was noticed to not be working after it was removed from the usm.The arm that the stapler instrument was installed onto was replaced after this event.The surgeon said this sureform 60 stapler instrument was ¿operating properly¿ until these two misfire events.The surgeon said he was surprised that they received errors stating the tissue was too thick because the portion of tissue left was small.The surgeon said he believes a white stapler reload should have been enough to handle the remaining amount of tissue.The robotics coordinator from the site reported the da vinci system used during this procedure initially powered on without errors and the usm worked well previously in the procedure; however, multiple instrument engagement issues occurred towards the end of the procedure after the tissue had been removed from the jaws of the sureform 60 stapler instrument.The robotics coordinator reported that the sureform 60 stapler instrument and white stapler reload fired during this event were both discarded and therefore cannot be returned.No pictures or videos were taken of this event.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14112165
• MDR Text Key: 289271245
• Report Number: 2955842-2022-11046
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)L93211220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: L93211220 0150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-02-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White