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

Model Number 380652-48

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Internal Organ Perforation (1987); Sepsis (2067)

Event Date 09/01/2021

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the root cause of the patient¿s post-operative complications leading to subsequent death is unknown although the surgeon indicated the cause of death was a combination of unspecified "technical error" and patient comorbidities.There is no allegation that a malfunction of a da vinci system, instrument or accessory occurred.If additional information is received, a follow-up mdr will be submitted.No image or video clip for the reported event was submitted for review.An isi field service engineer (fse) conducted a system log review and the results were as follows: based on on-site review, 139 procedures were completed after the event with no complaints reported.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.A medical review of the event information has been performed by an isi medical safety officer and results were as follows: "based upon the description of events, i am unable to determine the specific cause of the original gastric leak that ultimately led to the patient¿s death following a da vinci-assisted paraesophageal hernia repair." this complaint is being reported due to the following conclusion: after completion of a da vinci-assisted paraesophageal hiatal hernia, the patient experienced post-operative complications and expired.Per the surgeon, the cause of the patient¿s post-operative complication and subsequent death is due to multisystem organ failure due to intraabdominal sepsis from gastric perforation due to hiatal hernia repair.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Event Description

It was reported that after undergoing a da vinci-assisted paraesophageal hiatal hernia procedure, the patient experienced post-operative complications and expired.On (b)(6) 2022, intuitive surgical, inc.(isi) obtained the following additional information from the console surgeon regarding the reported event: after a da vinci assisted paraesophageal hiatal hernia surgical procedure for a (b)(6) female patient that was performed and completed on (b)(6) 2021, the patient expired on (b)(6) 2021.The surgeon stated that there were no issues intra-operatively with the da vinci surgical system or instrumentation.The surgeon reported that the procedure was difficult due to the patient¿s body habitus and the size of the hernia.There was copious omentum, mesentery and at least half of the stomach in the patient¿s chest.The hiatal hernia was reduced with difficulty which required a second assistant surgeon (with an assistant port) and the hiatal hernia was repaired.The procedure was completed robotically.The patient did well postoperatively within the first 24 hours, however, the patient was transferred to the icu for respiratory failure and hypotension.The patient underwent ct imaging and no perforation was found; however, on (b)(6) 2022, the patient was found to have a gastric perforation on the ct image.The patient returned to the surgery and underwent a gastric wedge resection procedure via open surgery.The patient initially improved; however, a leak at the wedge resection site was subsequently identified.It was noted that the patient had an "obvious staple line leak (by imaging, bilious drain output)." the patient underwent drainage of an associated abscess but refused further invasive interventions.Ultimately the patient transitioned to comfort care as the patient was uninterested in further surgeries.The hospital course was complicated by sepsis with acute kidney injury and atrial fibrillation with the rapid ventricular response.The patient expired on (b)(6) 2021.Per the surgeon, the cause of death was "myltisystem [sic] organ failure due to intraabdominal sepsis from gastric perforation due to repair of markedly symptomatic hiatal hernia." furthermore, the surgeon noted, "cause of death was, in my opinion, a combination of technical error and patient comorbidities.No issues with the robotic equipment leading to 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: 14221944
• MDR Text Key: 290192129
• Report Number: 2955842-2022-11263
• Device Sequence Number: 1
• Product Code: NAY
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/30/2022

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: 380652-48
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 157 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White