• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM Back to Search Results
Model Number 381121-30
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
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.The fse confirmed and reproduced the reported failure and replaced the integrated electrosurgical unit (iesu) viodv generator.After replacement, the system and the iesu were tested as a unit, iesu operated as expected.The system was verified as ready for use.Isi received the iesu involved with this complaint; however, device evaluation remains ongoing.A supplemental report will be submitted once failure analysis has been completed or additional information has been received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was available for review.Verification via system logs confirmed the occurrence of a procedure on the reported event date matching the documented event details.No related error was identified through the system logs.No further review is required as the logs were reviewed/analyzed as part of the isi tse and isi fse's investigation this complaint is considered a reportable malfunction due to the following conclusion: the integrated electrosurgical unit (iesu) viodv generator was replaced after the start of the procedure and the surgeon was able to continue with the procedure robotically with a third-party esu.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.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 procedure change.
 
Event Description
It was reported that during a da vinci-assisted gastrectomy (total) surgical procedure, an unspecified bipolar instrument was not recognized with the bottom port on the integrated electrosurgical unit (iesu) viodv generator.The customer received phone assistance from the technical support engineer (tse).Review of the site¿s system logs identified no related error.Upon verification, tse confirmed that a question mark prompt was displayed on the iesu generator.The other bipolar port on the iesu generator was working properly.The customer had performed a power cycle of the system and the iesu generator, replaced the instrument cable, and replaced the instrument but the issue persisted.Intuitive surgical, inc.(isi) followed up with the clinical sales representative (csr) and obtained the following additional information: system functionality was checked upon powering on the system.The iesu generator initially powered on without errors.The lower bipolar port could not be used during the procedure and the customer switched over to an external generator (activated through an external pedal) to continue the surgical task.The user continued with the procedure with no further issue reported.No known impact or patient consequence was reported.
 
Manufacturer Narrative
Intuitive surgical, inc.(isi) received the integrated electrosurgical unit (iesu) involved with this complaint and completed the device evaluation.Failure analysis s confirmed and reproduced the customer reported complaint.The iesu was placed on an in-house system and was run in an normal mode.
 
Event Description
Refer to h10/h11 for follow-up information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DAVINCI XI
Type of Device
VISION SIDE SYSTEM
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 Key14048645
MDR Text Key298471374
Report Number2955842-2022-10933
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110898
UDI-Public(01)00886874110898
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 Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381121-30
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2022
Initial Date Manufacturer Received 03/08/2022
Initial Date FDA Received04/07/2022
Supplement Dates Manufacturer Received04/20/2022
Supplement Dates FDA Received05/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2018
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
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
-
-