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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 380677-17
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse replaced the mtm. 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 has received the mtm for evaluation, however, device evaluation is still in progress. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if additional information is obtained. A review of the site's complaint history does not show any additional complaints related to this product, and/or this event. No image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted. 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. The product is not implantable.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, error 23008 occurred on surgeon side console (ssc) 2. The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and confirmed the error pointing to axis 8 on the master tool manipulator (mtm). The procedure was ongoing, but the customer was not able to use ssc2. The procedure was completed with no reported injury. Isi followed up with the initial reporter on 11/11/2020, and obtained the following additional information: the system was not checked prior to use. The second ssc was not used after the error occurred. The surgery was delayed by 10 minutes. The patient¿s status was "good. ".
 
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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 Key10877466
MDR Text Key221006674
Report Number2955842-2020-11231
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K131861
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,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-17
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2019
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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