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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the patient¿s operative complication is unknown.Isi has attempted to contact the site 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.Site history review: as of 14-sep-2021, a review of the site's complaint history shows a related complaint record was created to document the death case mentioned in the same journal article.Refer to mdr with patient identifier # (b)(6) for information regarding the death case.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.Based on the information provided, this complaint is reportable due to the following conclusion: within the journal article, various operative complications associated with robotic procedures were noted.Some of the operative complications required medical/ surgical intervention.However, at this time, the root causes of the complications 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 in was either unknown, unavailable, not provided, or not applicable.The event date in the information is unknown.Multiple product information are unknown due to limited product information being provided.Due to lack of product information, (510k no.) and (mfg date) are not available.It is unknown if the initial reporter submitted a report to the fda.

Event Description

On 30-aug-2021, intuitive surgical, inc.(isi) became aware of a 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.".

• Brand Name: DA VINCI
• Type of Device: PATIENT 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 Key: 12520434
• MDR Text Key: 273349409
• Report Number: 2955842-2021-11176
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• 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 Number: N/A
• Patient Sequence Number: 1