• 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 A70P6B
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 12/22/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) will not be receiving any parts for failure analysis. The isi field service engineer (fse) was not able to reproduce the reported failure and no parts were replaced. The 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 paitent harm occurred, if this malfunction were to recur it could cause or contribut to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted hysterectomy procedure, the customer experienced arm 1 and arm 3 locking up. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to press the emergency stop on the console and recover the fault and try again, however, the issue persisted. The tse had the customer reboot the system and turn off the finger clutch, but the issue was still occurring. The surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the facility but was not able to reproduce the reported failure.
 
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 Key7187341
MDR Text Key97752756
Report Number2955842-2018-00028
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 other
Reporter Occupation
Type of Report Initial
Report Date 12/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P6B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-