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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI PATIENT SIDE CART

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INTUITIVE SURGICAL, INC DA VINCI PATIENT SIDE CART Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Fistula (1862); Pseudoaneurysm (2605)
Event Type  Death  
Manufacturer Narrative
Based on the current information provided, the cause of the patient¿s post-operative complication and ultimate demise is unknown. Intuitive surgical, inc. (isi) has attempted to contact the author to gather additional information regarding the patient/incident. However, as of the date of this report, no new information has been obtained. If additional information is received, a follow-up mdr will be submitted. A review of the site's complaint history shows no complaints related to this event other than those based on the journal article. A system log review cannot be performed at this time since the event date and instrumentation is unknown and the system details are unconfirmed. No image or video clip for the reported event was submitted for review. There was no initial report or allegation from the journal article author, or any known allegation from a medical professional, of a specific deficiency of the da vinci system, instrumentation or accessories associated with the reported incident. Therefore, there are no products expected for return to isi for failure analysis evaluation. The complaint was reviewed by the isi medical safety officer and the following findings were obtained: based upon the information within the article entitled, ¿impact of body mass index on the early experience of robotic pancreaticoduodenectomy,¿ by y. J. Chao, et al. , updates in surgery, 2021; 73(3): 929-937, 68 consecutive patients underwent robotic pancreaticoduodenectomy between june 2015 and april 2020 at national cheng kung hospital. Of the 68 patients, one patient required reoperation due to a failed attempt to embolize a pseudoaneurysm of the gastroduodenal artery due to a postoperative pancreatic fistula. The patient developed multiple organ failure and died on postoperative day 114. The exact cause of the patient¿s postoperative pancreatic fistula is not provided in the paper. However, according to the paper entitled, ¿postoperative pancreatic fistula: a review of traditional and emerging concepts,¿ by c. B. Nahm et al, clinical and experimental gastroenterology, 2018: 11: 105-118, postoperative pancreatic fistula remains the main source of major morbidity and mortality after pancreatic resection, affecting between 13% and 41% of patients. Morbid sequelae include intra-abdominal sepsis and hemorrhage due to arterial rupture and carries a mortality risk of 1% for all patients. The mortality risk may increase up to 25% with higher postoperative pancreatic fistula grades. The risk for the development of a postoperative pancreatic fistula is related to gland texture, pancreatic duct diameter, intraoperative blood loss, and pathology of the resected pancreatic tissue. Additionally, obesity along with malnutrition are also risk factors. The author indicated that the patient in the article entitled, ¿impact of body mass index on the early experience of robotic pancreaticoduodenectomy¿ died to due complications of the postoperative pancreatic fistula. The cause of the postoperative pancreatic fistula is likely due to patient anatomical factors and disease pathology. It is unlikely that the da vinci system caused the patient¿s postoperative pancreatic fistula that led to the development the gastroduodenal artery pseudoaneurysm requiring a reoperation that led to sepsis, multiorgan failure, and ultimately death on postoperative day 114. This complaint is reportable due to the following: a patient underwent a robotic pancreaticoduodenectomy procedure which was complicated by a post-operative pancreatic fistula (popf). The patient required a reoperation due to the failed embolization of the popf. Eventually, the patient had multiple organ failure and died on a postoperative day 114. At this time, the root cause of the death as well as the medical/surgical intervention rendered, if any, are unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred or caused/contributed to the operative complications. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The date of death in outcomes attributed to adverse event as well as event date are blank as the information is unknown. The expiration date is not applicable. Implant date (2020 reports is blank because the product is not implantable. Fields pma/510k (2020 reports) and adverse event are not applicable.
 
Event Description
On 30-aug-2021, intuitive surgical, inc. (isi) became aware of an updates in surgery article titled, ¿impact of body mass index on the early experience of robotic pancreaticoduodenectomy¿ (chao, y. J. , liao, t. K. , et al. , 2021). Within the journal article, operative complications involving da vinci surgical procedures were noted: "all operations were performed using the da vinci si surgical system. Two patients (2. 9%) were converted to open surgery in the obese group due to severe inflammation at the pancreatic head and tumor adhesive to the superior mesenteric vein and none in the normal-weight and overweight groups. Thirty three patients experienced complications with an overall complication rate of 51. 5%, and the major complication rate (clavien grade
=
iii) was 19. 1%. There were 17. 6% clinically relevant post-operative pancreatic fistula (cr-popf) (16. 1% grade b popf, 1. 5% grade c popf), 8. 9% grade b/c post pancreatectomy hemorrhage (pph), 11. 8% grade b/c delayed gastric emptying (dge), and 5. 9% bile leakage. Twelve patients (17. 6%) had peripancreatic fluid collections, and eight of them required drainage. One patient required reoperation due to failed embolization of the pseudoaneurysm from the gastroduodenal artery due to popf. Eventually, the patient had multiple organ failure and died on a postoperative day 114. " isi has reached out to the author to obtain additional information but has not yet received a response.
 
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Brand NameDA VINCI
Type of DevicePATIENT SIDE CART
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12565269
MDR Text Key274420445
Report Number2955842-2021-11232
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
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 NumberN/A

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