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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED

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INTUITIVE SURGICAL, INC DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED Back to Search Results
Model Number 380721-01
Device Problems Overheating of Device (1437); Visual Prompts will not Clear (2281)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
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 avp (auxiliary video processor) to resolve the issue. The system was tested and verified as ready for use. Isi has not yet received the replaced components for evaluation. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. 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 the reported errors. This complaint is being reported based on the following conclusion: system unavailability after the start of a surgical procedure caused the procedure to be converted to a laparoscopic procedure 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 gastrostomy surgical procedure, the system displayed a non-recoverable error 297. Prior to contacting intuitive surgical inc. (isi) technical support engineer (tse) the customer indicated they had an overheating error message 95. The customer already removed the filter to ensure a proper ventilation of the vision side cart (vsc). Tse instructed the customer to power cycle the system, including turning the circuit breaker to the off position. After rebooting the system, the error 297 pointing to a fault on auxiliary video processor (avp3) reoccurred. Tse reviewed the logs and identified an error 310 had also occurred the previous days, pointing to the same component, avp3. Tse informed the customer about the root cause for the problem. The surgeon decided to convert to a laparoscopic surgery. There was no report of 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 NameDA VINCI XI
Type of DeviceVISION SIDE SYSTEM, RECONDITIONED
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 Key13057298
MDR Text Key288493608
Report Number2955842-2021-11789
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874115343
UDI-Public(01)00886874115343
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380721-01
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
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 Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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