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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM Back to Search Results
Model Number 381121-24
Device Problem Loss of Power (1475)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/11/2023
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the customer converted the procedure to open surgery due to powering down of the patient side cart (psc).However, through troubleshooting, it was determined that the psc circuit breaker was set to the off position, and this caused the psc to run in battery mode and eventually to lose power.The intuitive surgical, inc.(isi) technical support engineer (tse) instructed the customer to set the psc circuit breaker to the on position to correct the issue.The system was working properly, and no additional action was required.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, that the system was running in battery mode.Caller took no action.Shortly after starting the procedure, the patient side cart (psc) powered down.The customer managed to remove the instruments from the patient and the procedure was converted to open surgery.The customer called intuitive surgical, inc.(isi) technical support engineer (tse) after the customer already converted the procedure.According to the customer, this surgery had a high risk to be converted to an open surgery right from the beginning.During troubleshooting, it turned out that the circuit breaker from the psc had been set to the off position.After correcting that issue, the psc was working.Its battery was charging.The procedure was converted to open surgery with no patient harm.Isi followed up with the initial reporter and obtained the following additional information: the tumor was quite large.The high risk of conversion was already known, and the patient was prepared for an open procedure from the very beginning.The patient tolerated the open procedure very well.The patient was not injured.Ports were placed at the time of the conversion to open surgery.During set up, the customer had identified that the system was running on battery power, but the cause could not be identified.The system was checked before use and immediately called the hotline.
 
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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 Key17906106
MDR Text Key325301428
Report Number2955842-2023-19067
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110898
UDI-Public(01)00886874110898
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,Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 09/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381121-24
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/11/2023
Initial Date FDA Received10/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2017
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
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