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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 380652-46
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Date 11/15/2021
Event Type  Death  
Event Description
It was initially reported by a nurse from the site that during a da vinci-assisted pulmonary wedge resection, the patient's pulmonary artery was torn as a result of a robotic arm that had allegedly drifted and the patient expired. The intuitive surgical, inc. (isi) clinical sales representative (csr) obtained the following information from the nurse and console surgeon¿s partner: the nurse was reportedly not present during the case; however, she corresponded with the console surgeon who reportedly indicated that he no longer believes the event was caused by unexpected arm movement of the patient side cart (psc) and thinks the event was somehow caused by him. The console surgeon¿s partner speculates that the console surgeon hit the arm swap button without realizing it, inadvertently moved the retracted arm, and damaged the pulmonary artery with the installed stapler instrument. The console surgeon¿s partner said there was a stapler instrument across the pulmonary artery that was ready to fire but had not yet been fired. It is unknown how the console surgeon¿s partner became aware of the event details or if he was present during the case.
 
Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication cannot be determined. An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The initial reported complaint that a robotic arm had drifted or moved unexpectedly was not confirmed based on the field evaluation.  the fse visually inspected the system and did not notice any damage. The fse inspected all universal surgical manipulators (usm) and did not notice any physical damage, with the exception of scratches on covers on all usm's (cosmetic only). No major damage to the usms were identified. The fse verified that the head sensors on both surgeon side consoles (ssc) were working properly. The fse also verified that the sterile adapters engaged properly on each usm and seated correctly. All sensors were found to be functioning properly. The system was tested and verified as ready for use. A review of the site's system logs has been performed by an isi failure analysis engineer (fae) for the procedure in question. No errors were identified in the system logs in relation to non-intuitive movement or drifting of arms. The instrument logs show that one sureform 45 instrument was used and fired 1 blue reload. The firing was completed with no pauses for compression per the logs. A stapler 30 curved-tip instrument was installed 5 times but only fired 1 reload (white), which occurred on install #3. The firing of the white reload was completed per the logs. The last install of the stapler 30 curved-tip instrument, did not have any clamp or fire attempts. A second white reload was installed but was never fired. All multi-use instruments used in the case have been used in subsequent procedures with the exception of the single-use instruments and the following instruments: permanent cautery spatula (pcs), long tip forceps, sureform 45, and fenestrated bipolar forceps (fbf). The fbf had 0 lives remaining after the case was performed. As of (b)(6) 2021, a review of the site's complaint history did not find any related complaints associated with the instruments used during the procedure. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the pulmonary artery was injured and the patient subsequently expired. After the event occurred, an fse inspected the system and was unable to reproduce the initial allegation by the customer that an arm drifted or moved unexpectedly. At this time, the cause of the intra-operative complication is unknown.
 
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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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12995502
MDR Text Key282179977
Report Number2955842-2021-11738
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-46
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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