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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS Back to Search Results
Model Number 380677-03
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Image/video review: no image or video clip for the reported event was submitted for review. System log review: a review of the site's system logs for the reported procedure date was conducted by the intuitive surgical, inc. (isi) technical services engineer (tse). Investigation revealed the following possible related system errors: error 25521 communication link problem. An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse replaced the right mtm due to error 25521. The system was tested and verified as ready for use. The (mtm) refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console. One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr). Isi received the mtm involved with this complaint and completed the device evaluation. Failure analysis investigation replicated the reported error during the sine cycle. This complaint is being reported because the surgeon side console was unavailable after procedure start. While there was no harm or injury to the patient, the reported failure mode contributed to the procedure being converted to laparoscopic surgery and 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 surgical procedure, non-recoverable error 25521 occurred pointing to the left master tool manipulator (mtm). The site disabled the mtm and removed all installed instruments then power cycled; the error returned on power up. The site hard power cycled the surgeon console but the error persisted. The site hard power cycled again with no change. The site was unable to convert to another da vinci system and decided to convert the procedure to traditional laparoscopic surgery. The procedure was converted to traditional laparoscopic surgery with no reported injury.
 
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Brand NameDAVINCI XI
Type of DeviceSURGEON SIDE CONSOLE, SMART PEDALS
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 Key10980186
MDR Text Key238927836
Report Number2955842-2020-11327
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-03
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2014
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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