• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS4000 A70P7B
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the master tool manipulator (mtm) involved with this complaint and completed investigation. Failure analysis investigation reproduced the reported failure during sine cycle.
 
Manufacturer Narrative
(b)(4) has not received the unit for failure analysis. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. This complaint is being reported due to a da vinci system malfunction 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 cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the customer experienced an error on the right master tool manipulator (mtm). 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 side console (ssc). One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr). The procedure was converted to laparoscopic surgery. There was no report of patient harm, adverse outcome or injury. (b)(4) (isi) received the following additional information: the robot worked without issue before the error occurred. Troubleshooting was performed, however, the surgeon was unable to continue with the surgery. The conversion was not planned but the case completed laparoscopically without harm to the patient. An isi field service engineer (fse) was dispatched to the site and was able to reproduce the reported failure and verified the error through the logs. The fse replaced the mtm to resolve the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI XI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7137466
MDR Text Key250279385
Report Number2955842-2017-00860
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P7B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-