MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-41

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/01/2021

Event Type  Death  

Event Description

It was reported that during a da vinci assisted hiatal hernia-paraoesophageal repair procedure, the procedure was converted to open due to patient anatomy.The patient sustained some tissue damage at some point during the surgery which required a second procedure to be done.After the second procedure, the patient expired on an unspecified date.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr), who was present during the robotic portion of the case and obtained the following additional information: the robotic surgery was converted to open surgery about 1.5 hours into the procedure due to patient anatomy.The patient had "tough" anatomy and the surgeon had issues getting a good plane to pull down the hernia.There were no known product issues that the csr was aware off.There was no excessive bleeding observed during the procedure.The csr is unaware of when the tissue damage occurred.The procedure was completed via open surgery, and the patient was sent back to the ward.Post-operatively, the patient had unspecified complications and was found to have gastro-esophageal junction tissue injury.The patient underwent a second procedure whereby a gastrostomy tube was placed.The patient eventually died.The patient was on long term steroids and had thin tissue.There are no products available for return.Isi followed up with the surgeon and obtained the following information: the surgeon is unwilling to share further information about the incident as he viewed that it was "ethically illegal" to report information pertaining this event to a third party.

Manufacturer Narrative

Based on the current information provided, the cause of the patient¿s post-operative complication and death are unknown.Isi has attempted to contact the surgeon to gather additional information regarding the patient/incident.However, as of the date of this report, the surgeon was unwilling to share further details about the incident.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.The instrument logs were reviewed by an intuitive surgical, inc.(isi) advanced failure analysis engineer (fae) and the following findings were obtained: a vessel sealer extend (vse) instrument was used during the case; however, no errors related to the vse instrument were found in the logs and only 4 ¿high initial starting impedance¿ messages were recorded by the e-100 generator.These messages indicate the impedance of the tissue between the jaws is higher than expected, likely due to clinical reasons.After each of these messages, the instrument seems to have been able to continue use as normal.There were no errors recorded that would indicate a potential failure of the vse instrument.The system logs were reviewed by an intuitive surgical, inc.(isi) senior director of technical support and the following findings were obtained: there were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.No image or video clip for the reported event was submitted for review.A medical review of the incident was provided by the isi medical safety officer (mso) and the following information was received: based upon the information provided in the description of events, the patient underwent an attempted da vinci-assisted hiatal / paraoesophageal hernia repair that required a conversion to an open surgical procedure due to anatomical difficulties which inhibited the ability to reduce the hernia sac robotically.There is no intuitive product related issue noted in the description of events.Post-operatively, the patient required a second operation where patient was noted to have a gastroesophageal junction injury.The patient eventually died.It is unknown as to the nature and degree of gastroesophageal junction injury.Furthermore, it is unknown as to when and how the patient sustained the injury.Given the noted challenges experienced during the primary procedure and the associated information on the patient¿s medical history (long term steroid use), it is reasonable to suspect that the root of this event lies within user error due to the reported difficult anatomy.However, the information listed above does not provide much information to evaluate this event more thoroughly.This complaint is a reportable adverse event due to the following: during a da vinci assisted hiatal hernia-paraoesophageal repair procedure, the procedure was converted to open due to patient anatomy.The patient had ¿tough¿ anatomy and the surgeon had issues getting a good plane to pull down the hernia.There were no known product issues during the procedure.The patient sustained some tissue damage at some point during the surgery which required unspecified additional procedures to be done.The procedure was completed via the open method.The patient had post-operative complications and a gastrotomy tube was subsequently inserted.The patient died eventually.The cause of the patient's intra-operative complication and subsequent death are unknown.There is no allegation of a malfunction of a da vinci system, instrument or accessory that caused or contributed to an injury or death.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 13178911
• MDR Text Key: 283385092
• Report Number: 2955842-2022-10015
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female