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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380614-12
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2020
Event Type  malfunction  
Manufacturer Narrative
A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was reproduced during field evaluation. The system alarmed with non-recoverable error 281 when powered on. The leds on psm1 were not lit. The leds on psms 2 and 3 and the endoscopic camera manipulator (ecm) were red. The fse reviewed the error log and identified error 23034 on psm1 followed by error 281 and error 307. The fse swapped psm1 and psm2, and the issue did not return. The fse swapped back psm1 and psm2. Per error 307, the fse suspected an issue between psm1 and embedded serializer setup joint (essj) 1. Per error 23034, the psm1 was determined as the cause of the event and was replaced. The system was tested and verified as ready for use. Isi received the psm involved with this complaint and completed the device evaluation. The reported complaint was not reproduced but could be confirmed as having occurred via a review of field error logs during failure analysis. A sine cycle and a test drive were performed without any issues. Tests performed via (b)(6) passed. The l4 switch will be replaced as a precaution. The psm2 was no trouble found. A review of the site's complaint history does not show any additional complaints related to this product. A review of the site's system logs for the reported procedure date was conducted by the fse. Investigation revealed the related system errors 23034, 281, and 307. Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, non-recoverable error 281 occurred, and all leds on the patient side manipulator (psm) were red. The intuitive surgical, inc. (isi) technical support engineer (tse) had the customer take out all instruments and power cycle the system, but the error persisted. The tse indicated that all troubleshooting steps were exhausted before the procedure was converted to laparoscopic surgery. The procedure was converted to laparoscopic surgery with no reported injury. It was further reported that the system was checked prior to starting the procedure, and no issues were noted. The patient was under anesthesia and ports were placed at the time of the issue. Instruments were being used at time of the issue. The system was used for approximately 40 minutes before the error occurred. Troubleshooting was performed before the procedure was converted to laparoscopic surgery. No patient harm or injury was reported.
 
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Brand NameDAVINCI SI
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key11183143
MDR Text Key266202989
Report Number2955842-2021-10051
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-12
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2014
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

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