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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 380610-14
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
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. The left screen in the high resolution stereo viewer (hrsv) of surgeon side console 1 was replaced to resolve the issue of black image during surgery. The system was tested and verified as ready for use. Isi has not yet received the replaced component 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 another da vinci 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. Blank mdr fields: follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date for section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Fields are not applicable.
 
Event Description
It was reported that during a da vinci assisted prostatectomy surgical procedure, there was no signal on one eye of surgeon side console (ssc) 1. The caller (doctor) indicated the display was fine on ssc 2. Due to the surgery being in progress, the surgeon did not want to troubleshoot the issue. Intuitive surgical inc. (isi) technical support engineer (tse) could not view live system logs. The procedure was completed with no patient injury. Additional information was obtained on 07-dec-2021. The tse reviewed system logs and confirmed that surgeon side console (ssc) 2 was used to complete the procedure. The isi field service engineer (fse) confirmed that the ssc1 was down during the surgery and a switch to ssc 2 was required to complete the procedure.
 
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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 Key13101747
MDR Text Key285412569
Report Number2955842-2021-11824
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081137
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380610-14
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2012
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: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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