MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED-TIP STAPLER 30

Model Number 470530-06

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/18/2020

Event Type  Death  

Manufacturer Narrative

(b)(4) - based on the current information provided, isi has not determined the root causes of the patients death.A follow-up mdr will be submitted if any additional information is received.Isi has reviewed the sites system logs with a procedure date of (b)(6) 2020.Logs show that the endowrist curved-tip stapler 30 instrument, part number 470530-06, lot t10190424-0023 fired three reloads (all white).All firings were completed per the logs and there were no issues with the stapler noted in the logs.Investigation into the cause of the reported downward motion of the stapler instrument was conducted and found no errors related to unintuitive or uncontrolled motion.Additionally, a review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue, and logged events are in line with normal system functionality.The log review supports the customer claim that there was no product issue during the case.Although instrument log review indicates that none of the instruments used during the procedure were used in subsequent procedures, site reviews have shown that no complaints were filed against the instruments.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted lobectomy surgical procedure, the patient experienced bleeding.As a result, the procedure was converted to an open surgical procedure, after which the patient reportedly expired.Although the surgeon indicated that there was no malfunction of the endowrist curved-tip stapler 30 instrument and there is no relationship between death and the endowrist stapler instrument," the surgeon stated that the stapler instrument had moved downward in the field of view about twice during the treatment of a3 and it was speculated that at that time, the root of the blood vessel was pressed and torn.Therefore, the cause of the intra-operative complication is unknown.Follow-up was attempted, but the patient information was either unknown, unavailable, or not provided.The expiration date is not applicable.There was insufficient product information available to determine the manufacture date.

Event Description

It was initially reported that during a da vinci-assisted upper left lobectomy procedure, bleeding was observed while the surgeon was approaching an unspecified vein with an endowrist curved-tip stapler 30 instrument.The bleeding was reportedly observed before the surgeon had clamped or fired with the stapler instrument.An assistant applied pressure to control the bleeding and the case was emergently converted to open surgery.Although the estimated blood loss was not confirmed, it was noted that a blood transfusion was administered.Three hours after the case was converted to open surgery, it was noted that the patients heartbeat did not return and the surgery ended.The surgeon indicated that there was no malfunction of the endowrist curved-tip stapler 30 instrument and stated that there is no relationship between death and the endowrist stapler instrument.Has also stated that conventionally, the accident rate is high when treating a3.The surgeon provided additional feedback after having reviewed the video of the surgical procedure and stated that the stapler instrument moved downward in the field of view about twice during the treatment of a3.The downward movement occurred prior to the stapling attempt.It was speculated by the surgeon, that there is a possibility that the root of the blood vessel was pressed and torn at the time of the approach of the stapler to the a3.Further clarification regarding the surgeons feedback regarding the downward motion of the instrument during the case has been requested.The patients death is determined to be due to hemorrhagic shock due to pulmonary artery injury.There are no reports of system or instrument malfunctions during the procedure.

Manufacturer Narrative

A review of the event was conducted by an isi medical safety officer and the following additional information was provided: based upon the information provided in the description of events, the patient experienced acute blood loss anemia and hypoperfusion after the a3 pulmonary artery was torn during a stapling and transection of the vessel.The cause of death was due to hypoperfusion due to the blood loss.It is unclear as to the cause the reported ¿downward¿ motion of the endowrist stapler.If the ¿downward¿ motion was controlled, then perhaps there is an element of technical error that may have contributed to the ¿crack¿ in the a3 pulmonary artery.Based upon the information, the cause of the intra-operative complication is unknown.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: CURVED-TIP STAPLER 30
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11041874
• MDR Text Key: 222547000
• Report Number: 2955842-2020-11377
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(10)T10190424
• Combination Product (y/n): N
• PMA/PMN Number: K152421
• 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: 11/18/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 470530-06
• Device Catalogue Number: 470530
• Device Lot Number: T10190424 0023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/27/2021
• 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; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Death