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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fluid Discharge (2686)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the cause of the patient¿s post-operative complication is unknown. There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. No product is expected to be returned for failure analysis as there was no allegation of a malfunction. The root cause of the customer reported failure mode cannot be determined at this time. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the system and instrument logs has been performed. 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. Additionally, all instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against the instruments. The logs were reviewed by an intuitive surgical, inc. (isi) advanced failure analysis engineer (fae) and the following findings were observed: ¿a few errors were seen in the logs, but nothing that points to an instrument failure; 3 ¿cut electrode shorted¿ events were recorded, indicating that arcing events were detected by the generator during use of the transect function. Arcing events that occur during transect and remain between the jaws of the instrument are an expected byproduct of the bipolar cut/transect function, and occurrence of such events depends on several clinical factors such as the amount of tissue grasped, amount of fluid surrounding the instrument, type of tissue, etc. Additionally, there were 17 ¿high initial starting impedance¿ messages recorded, which indicate the impedance of the tissue between the jaws was higher than expected by the generator. This message does not indicate an instrument failure and is usually due to a clinical reason or technique. For example, sealing multiple times over the same area (banding), sealing over already desiccated tissue, etc. The proximity of these impedance error messages to other, shorter, coag activations suggests these seal activations may have been errant. " no image or video clip for the reported event was submitted for review. This complaint is being classified as a reportable event due to the following conclusion: after a da vinci-assisted total gastrectomy procedure, the patient developed lymphatic leakage which required prolonged drainage. The patient's hospital stay was prolonged by 2 weeks due to the issue. The customer confirmed that there was no malfunction of an isi system, instrument, or accessory during the procedure. The procedure was completed as planned. A review of the instrument and system logs did not suggest a product or system issue. The logs were reviewed by an intuitive surgical, inc. (isi) advanced failure analysis (afa) engineer and there was no evidence of instrument failure seen. The synchroseal was reported to have sealed sufficiently during the procedure with no issues noted. However, the customer was unsure if the event might be related to the synchroseal usage. Moreover, the customer used a laparoscopic clip, synchroseal and fenestrated bipolar forceps to seal the lymphatic channels during this surgery, and it is unknown what caused or contributed to the prolonged lymphatic leakage. The prolongation of hospital stay is a medical intervention to preclude permanent impairment, making this complaint a reportable adverse event. At this time, the cause of the event remains unknown.
 
Event Description
It was reported that after a da vinci-assisted total gastrectomy surgical procedure, the patient developed lymphatic leakage which required prolonged drainage. The hospital stay was prolonged by 2 weeks due to the issue. The patient did not receive any unplanned medical/surgical intervention. It was unknown whether there was a correlation between the issue and the use of the synchroseal instrument. The procedure was completed as planned. Intuitive surgical inc. (isi) followed up with the customer and obtained the following information: the instruments were inspected before use and there was no damage seen. The site confirmed that there was no cautery issue seen with the synchroseal instrument. The size of the tissue bundle was less than 5 mm, the tissue fit into the jaws properly, there was no calcified vessel, and no submersion of instrument in liquid during the sealing process. There was also no contact of the instrument jaws with any hard material or contamination of the jaws by carbonized tissue. No arcing was seen with the synchroseal nor did any error messages appear with the use of the synchroseal. There was no thoracic duct or cisterna chylii injury intra-operatively. The customer confirmed that there was no malfunction of an isi system, instrument or accessory that occurred. Post operatively, the patient had prolonged lymphatic leakage which required prolonged drainage. Patient-related information including demographic information and medical history was requested but not provided.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT 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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12148083
MDR Text Key268071806
Report Number2955842-2021-10753
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-40
Device Catalogue Number380652
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2018
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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