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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-48
Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
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 reported complaint was not reproduced during field evaluation. The universal motion controller (umc) was replaced. The system was tested and verified as ready for use. Isi received the umc for failure analysis investigation, however, the investigation is still in progress. Therefore, the root cause of the customer reported failure has not been determined. A follow-up mdr will be submitted to the fda once the failure analysis investigation has been completed and/or if additional information is received. Instrument logs for the system were not available for review. 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. The procedure was converted to a laparoscopic surgery. 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 surgical procedure, error 319 was observed. The nurse restarted the system, but universal surgical manipulators (usm) 2 and 3 were not lit. The procedure was converted to laparoscopic surgery with no reported injury. On 22-december-2020, intuitive surgical, inc. (isi) obtained the following additional information from the customer: the system powered on before port placement. The system functionality was normal, and there were no errors. The customer contacted the isi field service engineer (fse) for troubleshooting assistance at the time when the error occurred, but the issue could not be resolved. The nurse had no information about the patient's current status. Patient demographic information was requested, but the site was unwilling to provide further information. On (b)(6) 2021, the fse confirmed ports were placed on the patient. The operation was not aborted. The operation was converted to laparoscopic surgery.
 
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Brand NameDAVINCI XI
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 Key11188237
MDR Text Key240954735
Report Number2955842-2021-10059
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-48
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2020
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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