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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 380652-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Adhesion(s) (1695)
Event Date 12/02/2021
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the cause of the conversion of a portion of the procedure to open is due to patient anatomy. A follow-up mdr will be submitted if additional information is received. An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Universal surgical manipulator (usm) 4 was replaced to resolve the error 32056 issue. The system was then tested and verified as ready for use. The usm was returned and evaluated by isi. The reported complaint (occurrence of error 32056) was confirmed, but not replicated during in-house testing. A review of the system logs confirmed that errors 32101, 32056, 48100 and 32058 were generated by the system and pointed to the axes controller motor (acm). However, the unit passed all tests when installed on a patient side cart (psc) fixture test platform and other test platforms. The acm printed circuit assembly (pca) was replaced as a precautionary measure. A review of the system and instrument logs has been performed. The logs showed error 32056 occurring. All reusable instruments used in the case were used in subsequent procedures with the exception of the fenestrated bipolar forceps and small grasping retractor and a site review shows no complaint filed against these instruments. No image or video clip for the reported event was submitted for review. The system logs were reviewed by an isi failure analysis engineer (fae) and the following findings were obtained: about an hour and a half after the start of the procedure, arm 4 experienced 32101 errors (which also led to some other errors including the 32056). The site tried recovering a few times, but the errors returned. Eventually the customer disabled the arm which allowed the error to be recovered but then restarted the system. When the system was turned back on, the arm was no longer disabled, causing the errors to return. The customer repeatedly disabled the arm and restarted the system. The third time the customer disabled the arm, they turned off the system and did not restart it. The customer experienced an issue with arm 4 which could not be recovered from. The customer elected not to continue using the system as a 3-arm system. This complaint is being reported due to the following conclusion: during a da vinci-assisted right hemicolectomy procedure, the surgeon decided to extend the surgical incision to perform an extra-corporeal anastomosis due to adhesions and small body habitus of the patient.
 
Event Description
It was reported that during a da vinci-assisted right hemicolectomy procedure, the surgeon elected to extend the incision line to perform an extra-corporal anastomosis due to the patient having extensive adhesions and small body stature. While in the process of undocking the system to perform extra-corporal anastomosis, arm 4 had a non-recoverable fault 32056. The site tried to recover the arm 4 fault but the error recurred. The site then tried to disable arm 4 by putting it in a stow position, but the error returned again. As the system was in a faulted mode, the surgeon was unable to go into following and control the instruments on the other arms. Since the instrument on arm 1 was grasping tissue, the instrument release key (irk) was used to open the jaws of the instrument to release tissue. The surgeon had already elected to perform the anastomosis extra-corporeally, prior to when the arm 4 issue occurred. The fault on arm 4 only occurred during the undocking process. The surgery was completed and there was no injury/harm to the patient. The procedure delay due to the fault and subsequent irk use was 5-10 minutes. The site called an intuitive surgical, inc. (isi) technical support engineer (tse) at the end of the procedure; however, the error 32056 issue associated with arm 4 was not resolved despite troubleshooting. The tse guided the site with disabling arm 4; therefore, the system could still remain usable as a 3 arm system. There were no reported post-operative complications and the patient was noted to be recovering well. There were no videos/images available for viewing. Demographic information/relevant investigation and relevant medical history were enquired 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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13102398
MDR Text Key285613797
Report Number2955842-2021-11829
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-50
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2021
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

Patient Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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