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

Model Number 410298-11

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the post-operative cerebral hemorrhage is unknown.Isi has requested for the stapler 45 instrument, a blue stapler 45 reload, and stapler motor pack (smp) for evaluation.However, as of the date of this report, isi has not received the products for failure analysis.A follow-up mdr will be submitted if additional information is obtained.Isi has reviewed the site¿s system logs.The first smp/stapler combo used was smp (serial # (b)(4)) with stapler (part #410298-11; lot #s10170215-823) with a blue stapler 45 reload installed.While this combo was installed, the system logs show multiple error 32070 pointing to communication issues between the smp and icb.In addition, a single low rom homing failure occurred and two error 32030 faults were generated.The system was power cycled two times.There were no clamps or fires attempted with this stapler instrument and smp combo.Later in the procedure, the surgical staff replaced the smp and stapler instrument.The surgical staff used smp (serial # (b)(4)) with stapler 45 instrument (lot #t10180613-728) with blue stapler 45 reloads installed.With this combo installed, the logs show that six blue stapler reloads were fired; however, only five of the firings were completed.A partial fire (error 32075 in system logs) occurred on the fifth firing.The firing failed at 79% completion.There was one incomplete clamp in two clamp attempts on this install.There were no other installs that had incomplete clamps).Around 1.5 hours after the last stapler firing, smp (serial # (b)(4)) with stapler 45 instrument (lot # s10170215-823) were installed again.During this install, the system logs show more error 32070 faults pointing to a voltage/current error on the smp.There was one homing failure.No clamps or fires were attempted with this stapler instrument and smp combo.Isi has reviewed the site's complaint history.No related complaints have been identified.This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted gastrectomy procedure, the patient suffered a cerebral hemorrhage.As a result, the patient underwent another unspecified surgical procedure.However, the cause of the post-operative complication is unknown.Blank mdr fields: follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.Implant date is blank because the product is not implantable.The sections are not available for the site.

Event Description

It was reported that after undergoing a da-vinci-assisted gastrectomy procedure, the patient suffered a cerebral hemorrhage and required another unspecified operation.The surgeon reportedly commented that ¿it cannot be said that it is a direct cause, but it was a patient with a tendency to bleed from the preoperative stage.¿ during the da vinci-assisted surgical procedure, the surgical staff encountered an error 32030 issue while using a stapler 45 instrument.An error 32030 is generated when the system cannot communicate with one of the instrument control box (icb) nodes.When the error is generated, stapler instruments may not be supported.At that moment, the surgical staff contacted an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance.After the surgical staff performed a hard power cycle of the vision side cart (vsc) and replaced the stapler 45 instrument, the error 32030 issue was resolved.At that time, there was no report of any patient harm or injury.It was reported that approximately 3 hours later, the surgical staff encountered an error 32075 issue in the middle of stapler fire.An error 32075 is a recoverable fault that is generated when the system detects that the firing operation could not be completed.The surgical staff contacted a tse again for assistance.After recovering from the fault and removing the stapler instrument, the surgical staff installed a new stapler reload on the instrument.The surgical staff then reinstalled the stapler instrument and proceeded with the procedure.The surgeon commented that due to the trouble of the stapler instrument(s), the surgical procedure took an extra hour than the original scheduled operation time.At an unspecified time post-operatively, the patient experienced a cerebral hemorrhage.As a result, the patient underwent another unspecified surgical procedure.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in sections d10, g4, g7, h2, h3, h6, and h10.Device evaluation information can be found in sections h6 and h10.67 - intuitive surgical, inc.(isi) has received the stapler 45 instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed through the error logs that a stapler error occurred as reported by the customer.A review of error logs showed that the stapler 45 instrument was used with a stapler motor pack (smp) at the site on (b)(6)2020 using da vinci system #sk2147.When placed on the system at the site as a combo unit, error 32070 and error 32049 occurred several times.Error 32070 is a fault of the smp sensor and error 32049 signifies an instrument control box (icb) issue.There was also one low rom initialization failure (error 32064) but the majority of the errors were due to 32070 and 32049.The stapler 45 instrument was tested again at isi with several in-house smps.The unit combo passed and initialization passed.No trouble was found with the stapler 45 instrument during in-house testing.Clamp and fire function passed with the combo unit.A blue light lit up on the icb on all the installation attempts indicating power was being delivered and the unit was properly connected.Isi has received the smp associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of "poor contact on connector, error" through error logs.Several in-house stapler instruments were attached successfully on the smp.The icb indicator light turned blue which indicated that the unit was recognized.The unit passed self-initialization on multiple attempts and on different arms.No initialization or fault failures occurred during in-house testing.Isi has received a blue stapler 45 reload associated with this complaint and completed investigations.The stapler reload was found to have the knife exposed within the knife track.The stapler reload was found to have a firing failure.Log review showed that this stapler reload was fired partially on da vinci system #sh2147 on (b)(6)2020.The known common cause of this failure is mishandling/misuse.An additional observation not reported by the customer was that the knife of the reload was found with an indentation to the blade edge.The known common cause of this failure is mishandling/misuse.Another observation not reported was body cartridge damage that appeared near the site of the exposed knife.No material appeared to be missing as the surface of the cartridge appeared to have material lifted off.The known common cause of this failure is mishandling/misuse.

Manufacturer Narrative

Updated information can be found in the following fields: g4, g7, h2, and h10/11.Corrected information can be found in the following fields: e2, e3, and g3.

Event Description

Refer to h10/h11 for follow-up information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just an adverse event as previously reported due to the report of postoperative leak, which could potentially be related to a product problem.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9925273
• MDR Text Key: 196476244
• Report Number: 2955842-2020-10276
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093(10)S10170215
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410298-11
• Device Catalogue Number: 410298
• Device Lot Number: S10170215 823
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/11/2020; 08/17/2020; 03/05/2020
• Supplement Dates FDA Received: 05/08/2020; 09/11/2020; 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Outcome(s): Life Threatening; Required Intervention