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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
Model Number 380677-22
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Fse replaced the remote arm controller (rac) 2 to resolve the reported error 23 issue. The system was tested and verified as ready for use. Intuitive surgical, inc. (isi) received the rac involved with this complaint and completed the device evaluation. Failure analysis investigation could not reproduce the reported issue; however, the reported error 23 was confirmed via error logs/system logs. When the rac was installed and tested on an in-house system, the unit passed multiple power cycles and sine cycles without error. Additionally, a master tool manipulator was used to manipulate the position of arm 4, without issue. A review of the site's complaint history does not show any additional complaints related to this product. No image or procedure video was provided. Fse reviewed the system logs at the time of the call into technical support. The logs confirmed that the reported errors occurred, but there was no trouble detected during testing of the product. This complaint is being reported based on the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the system displayed a non-recoverable error 23. The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and confirmed the error, pointing to the right master tool manipulator (mtm) on surgeon side console (ssc) 1. The reporter (a nurse) indicated the error would reoccur when the surgeon attempted to control universal surgical manipulator (usm) 4. To avoid further interruptions, the operating room team decided to proceed with the case using a second ssc. The procedure was completed as planned with no reported injury. Isi followed up with the reporter to request additional information. However, no further information has been received as of the date of this report.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
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 Key12530752
MDR Text Key273351537
Report Number2955842-2021-11187
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110744
UDI-Public(01)00886874110744
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 foreign,health professional,o
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-22
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2020
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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