• 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 EQUIPMENT MORCELLATOR 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. DA VINCI EQUIPMENT MORCELLATOR SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Type  Injury  
Event Description
In (b)(6) 2019, iq, a (b)(6) y/o married, mother of a three y/o child, underwent a minimally invasive robotic hysterectomy for treatment of symptomatic uterine tumors assumed to be benign fibroid disease of (b)(6). The operating surgeon was (b)(6) from "(b)(6) ob/gyn". The diagnosis of uterine leiomyosarcoma was pre-operatively missed in this pt. According to the pt, her surgeon explained that her malignant uterine tumor was morcellated in order to accomplish the small incision robotic hysterectomy operation. She reports that she was no pre-operatively informed of the need for morcellation and that no discussion took place regarding the possibility that a missed / occult cancer could masquerade as a fibroid tumor and be spread or upstaged by morcellation. It is unclear whether the surgeon used the robotic equipment as a morcellator to disintegrate the uterine tissues / tumors or if a laparoscopic power morcellator device was used in the operation - and if so, whether a containment bag was used. Irrespective, the pt underwent morcellation of her cancer despite concerning pre-operative clinical criteria and without having been informed of the potentially deadly risk of cancer upstaging. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDA VINCI EQUIPMENT MORCELLATOR
Type of DeviceSYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key9317353
MDR Text Key166740554
Report NumberMW5091044
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 Other Health Care Professional
Type of Report Initial
Report Date 11/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
-
-