• 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 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has completed investigation on the master tool manipulator (mtm). Failure analysis investigation confirmed the reported failure during sine cycle.
 
Manufacturer Narrative
Intuitive surgical inc. (isi) received the master tool manipulator (mtm) involved with this complaint, however, the device evaluation is still in progress and has not been completed. A follow-up mdr will be submitted once the device evaluation has been completed or if additional information is received. This complaint is being reported due 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 the reported malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted sacrocolpopexy procedure, the customer received several 23025 recoverable faults. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the (isi) clinical sales representative (csr) to power down and exercise the left master tool manipulator (mtm) to resolve the error. The csr had pressed the override to recover the fault and the site continued as planned. The csr called back to report the 23025 fault on axis 3 of the left mtm was now occurring every 30 seconds. Isi made a follow up attempt and obtained the following additional information: the csr stated the fault was happening every 30 seconds. She said this caused the error to appear (30 - 40 times). The surgeon made the decision to convert the procedure to a traditional laparoscopic procedure since the left mtm was not working. An isi field service engineer (fse) was dispatched to the facility and was not able to reproduce the reported failure, but was able to view the error in system logs. To resolve the issue, the fse replaced the left mtm. The mtm refers to the master controller which provides the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon side console. One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).
 
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 Key7157208
MDR Text Key158779300
Report Number2955842-2018-00001
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2018
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 Manufacturer12/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-