MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; STAPLER 45

Model Number 410298-11

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

The stapler 45 instrument used during the da vinci-assisted surgical procedure has not been returned for analysis.Therefore, the root cause of the alleged customer reported issue cannot be determined.If additional information is obtained, a follow-up mdr will be submitted.Isi advanced failure analysis (afa) engineer performed a log review and provided the following results: "logs show an unclamp failure that occurred with stapler part number 410298-11, lot t10180620-755 and stapler motor pack serial number (b)(4) with a blue stapler 45 read installed.The issue occurred on the second install.The first install had six incomplete clamps in seven clamp attempts, and after the completed clamp, the stapler fired a blue reload and completed the firing per the logs.On the next (second) install, the stapler had eighteen incomplete clamps in eighteen clamp attempts and following the 18th clamp, the subsequent unclamp failed.Error 32073 was recorded in the msc logs, which is for an unclamp failure.The unclamp failure would display a message instructing the user to use the srk." site history review was conducted on 1-dec-2020 and found no additional complaints related to the product.No image or video clip for the reported event was submitted for review.It was reported that the surgeon acknowledged that the use of the blue reload may have not been appropriate since multiple clamps were required.The instrument & accessory user manual states: warning: always inspect the tissue thickness and select an appropriate stapler reload before application of a staple line using the stapler.Improper reload color selection (staple size) can result in over-compression or under compression of tissue and improper staple formation.Based on the information provided at this time, this complaint is reportable due to the following: the endowrist stapler 45 instrument failed to release from tissue when commanded by the user or system.The use of an srk was required to release the stapler from tissue.It was confirmed that the failure occurred after the stapler clamped, before it fired.Although, there is a report of bleeding, it was confirmed that the bleeding was not significant.Although there was no harm to the patient reported, if this failure mode were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, when the customer tried to resect with the stapler 45 blue cartridge, a "yellow error" occurred and the stapler 45 instrument got stuck with the tissue "bitten." it was reported that a message prompting the user to use the release kit was being displayed so the customer followed the instructions to use the release kit.The customer stated that another instrument was installed and fired to complete the procedure.The surgeon acknowledged that the use of the blue reload may have not been appropriate since multiple clamps were required.The procedure was completed as planned with no additional issues.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and no abnormalities were noted.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws, but the surgeon had to clamp four or five times for the instrument to fire.The customer acknowledged that tissue thickness may have been inappropriate for the blue reload.The use of the two da vinci staplers took 30 minutes.The stapler release key (srk) was able to successfully open the jaws and release the tissue.Little bleeding was experienced by the customer but the exact quantity of bleeding is unknown.It was confirmed that the bleeding was not significant.

Manufacturer Narrative

4315- intuitive surgical, inc.(isi) has received the stapler 45 instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed through error logs the customer reported complaint.For clarification, the instrument experienced an unclamp failure.Failure analysis found the primary failure of an unclamp failure to be related to the customer reported complaint.Log review showed an error 32073 'unclamped failed' occurred at the site using system sh1821 on (b)(6) 2020.Error 32073 states ¿the stapler stalled while attempting to unclamp.It may be partially or completely clamped on tissue." this could be caused by excessive friction in the stapler 45 instrument or the stapler motor pack.The stapler 45 was placed on a da vinci system and initialization passed on multiple attempts.Fire, clamp, and unclamp function was tested and passed successfully.Staple formation from the new reload was proper and had no issues.The following additional observations not reported by customer were identified.The stapler 45 instrument was found with a cracked pivot plate.The known common cause of this failure is mishandling/misuse.Failure analysis found the cracked pivot plate to be related to the customer reported complaint.Laser mark corrosion of the anvil was identified.Marks were found faded and not visible in certain areas.Failure analysis found the additional failure of laser mark corrosion to not be related to the customer reported complaint.Isi has received the stapler sheath associated with this complaint and completed investigations.Visual inspection was conducted and found a tear approximately 0.038" x 0.395" located at the middle of the sheath.There were no missing pieces.The root cause of this failure is attributed to mishandling.Isi has received the reload associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the customer reported complaint.Upon visual inspection, the returned reload appeared to be unused and unfired.The reload was installed in an in-house stapler and placed on the in-house system.A "used reload installed.Remove instrument and replace reload¿ message was observed.This implied that the reload was previously placed on a system.No damage was found and there was no problem detected.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10933582
• MDR Text Key: 240638095
• Report Number: 2955842-2020-11286
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093(10)T10180620
• Combination Product (y/n): N
• PMA/PMN Number: K113706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410298-11
• Device Catalogue Number: 410298
• Device Lot Number: T10180620 755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES