• 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 SI 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 SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A6.0P6
Event Date 03/28/2012
Event Type  Injury  
Event Description

It was reported that during a da vinci si gastric bypass procedure the surgeon was unable to move patient side manipulator (psm) arm 2 from the surgeon console. After restarting the system, psm arm 2 worked fine. After 15 minutes of operation the surgeon lost control of psm arm 1, resulting in damage to the patient's stomach. No further injuries were reported.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

The system logs were reviewed by an isi technical support engineer and no errors were observed which indicate that there were issues with the psm arms. The psms are instrument arms located on the patient cart that provide the sterile interface for the endowrist instruments. The root cause of the surgical complication experienced by the patient is currently undetermined. Multiple attempts have been made to gain additional information about the event, but the customer has yet to provide further details. If additional event details become available a follow up mdv will be submitted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI SI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2552349
Report Number2955842-2012-00184
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS3000 A6.0P6
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received03/28/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/29/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES
-
-