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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI SURGEON SIDE CONSOLE Back to Search Results
Model Number 380677-10
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
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 to resolve the issue. The system was tested and verified as ready for use. Isi has not received the mtm for evaluation. 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 procedure video was provided 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 caused the procedure to be converted to a laparoscopic procedure. This could potentially lead to an injury due to the patient¿s inability to tolerate a conversion. 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.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, it was not possible to use the master tool manipulator (mtm). The intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and found error 25520 pointing to faulty voltage in the mtm. The tse asked the site to power cycle the system; however, after startup the issue remained. The tse guided the surgeon to power down the system, exercise the mtm, and hard power cycle the surgeon side console (ssc); however, the issue remained. The procedure was converted to laparoscopic surgery with no reported injury. Isi followed up on 22-jun-2021 and obtained the following additional information: the system was inspected prior to use. There were no issues noted during set up of the system. The procedure was successfully completed laparoscopically. The issue occurred at the very beginning of the procedure. There were no post-operative complications. The patient demographics were not provided.
 
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Brand NameDAVINCI XI
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12142526
MDR Text Key267897120
Report Number2955842-2021-10772
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
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 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380677-10
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2017
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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