• 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. VESSEL SEALER EXTEND SYSTEM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

  • 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. VESSEL SEALER EXTEND SYSTEM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480422
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2019
Event Type  malfunction  
Event Description
During robotic laparoscopic-assisted hysterectomy, bilateral salpingectomy, right oophorectomy and lysis of adhesions and iud removal, robotic vessel sealer malfunctioned while inside the patient. The vessel sealer would not release from the non-disposable trocar. No harm was detected. Device was retracted out of patient and will be shipped back to manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVESSEL SEALER EXTEND SYSTEM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94089
MDR Report Key8386157
MDR Text Key137807766
Report NumberMW5084585
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422
Device Catalogue Number230921
Device Lot NumberL10181126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-