MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; DA VINCI SURGICAL SYSTEM

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, isi has not determined the root cause of the alleged post-operative complication experienced by the patient.If additional information is received, a follow-up mdr will be submitted.This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted myomectomy procedure 1.5 years ago, the patient has experienced post-operative chronic pain.At one point, the patient sought medical attention from an er or urgent care due to the pain.However, it is unknown what medical intervention, if any, the patient received.In addition, the root cause of the post-operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Event Description

It was initially reported that after undergoing an unspecified da vinci-assisted surgical procedure on an unspecified date 1.5 years ago, the patient experienced post-operative discomfort and pain.As a result of the alleged post-operative complications, the patient visited an er or urgent care.It is unknown what date the patient sought medical attention and if any medical intervention was administered during the er/urgent care visit.On 03/06/2019, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event from the patient¿s sister: the patient was informed that "everything went well" during the da vinci-assisted myomectomy procedure.The surgical procedure was performed on an unspecified date back in (b)(6) 2017.Post-operatively, the patient has experienced chronic pain.The patient's sister did not know what medical intervention, if any, she received during the er or urgent care visit.The patient has spoken to various physicians regarding the post-operative pain.However, the cause of the post-operative pain has not been determined.

Manufacturer Narrative

On 03/15/2019, intuitive surgical, inc.(isi) received the following additional information from the patient¿s sister regarding the reported event: post-operatively, the patient has experienced chronic lower abdominal pain and nausea/vomiting.On an unspecified date, the patient had a follow-up, post-operative visit with the surgeon and an ultrasound was reportedly performed.The ultrasound results were noted to be "inconclusive." to her knowledge, the patient has only taken over-the-counter (otc) pain medications and no subsequent surgical procedures have been performed on the patient since (b)(6) 2017.Isi also contacted the risk management department of the site where the patient underwent the da vinci-assisted surgical procedure.The risk management department was unwilling to provide any information regarding the patient or surgical procedure.Based on the current information provided, this complaint will remain reportable due to the following conclusion: after undergoing a da vinci-assisted myomectomy procedure 1.5 years ago, the patient has experienced post-operative chronic pain.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Corrected data can be found in date of report.The initial mdr was submitted with an incorrect b4 date of this report entry of "02/05/2019." the correct date of this report entry for the initial mdr is "02/13/2019.".

Manufacturer Narrative

The event date has been corrected from blank to (b)(6) 2017.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: DA VINCI SURGICAL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8403467
• MDR Text Key: 138222908
• Report Number: 2955842-2019-10173
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Hospitalization