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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI SURGEON SIDE CONSOLE

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INTUITIVE SURGICAL, INC DAVINCI SI SURGEON SIDE CONSOLE Back to Search Results
Model Number 380610-21
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
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. Isi fse was not able to duplicate the reported issue; the system was functioning properly at the time of the initial test. Isi fse recalibrated the surgeon side console (ssc) touchpad and verified functionality. No parts were replaced. The system was tested and verified as ready for use. A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support. Investigation revealed no errors occurred during the surgical procedure that were related to the reported complaint. A review of the site's complaint history does not show any additional complaints related to this product. No image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient¿s inability to tolerate a conversion. 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 inguinal hernia-unilateral surgical procedure, "auto-calibration in progress" message was displayed on the console. The customer stated that they were unable to unlock the arms that were in use. Intuitive surgical, inc. (isi) technical support engineer (tse) had the customer power down the system and cycle the surgeon side console (ssc) breaker. The customer powered the system back on and while installing instruments, the ssc touchpad went back to the login screen. The customer tried to unlock the arms, but they would not unlock. The customer then informed the isi tse that the surgeon had decided to convert to laparoscopic procedure. The error logs showed no arm or ssc touchpad-related errors. The procedure was completed laparoscopically with no reported injury. Isi made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameDAVINCI SI
Type of DeviceSURGEON SIDE CONSOLE
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 Key13081744
MDR Text Key285750412
Report Number2955842-2021-11801
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110683
UDI-Public(01)00886874110683
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380610-21
Device Catalogue Number380610
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2016
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: 12/23/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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