MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI EQUIPMENT MORCELLATOR SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT

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).

• Brand Name: DA VINCI EQUIPMENT MORCELLATOR
• Type of Device: SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 9317353
• MDR Text Key: 166740554
• Report Number: MW5091044
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/12/2019
• 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