MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; PATIENT SIDE CART

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the system and instrument log cannot be conducted at this time as the event date and da vinci system information remain unavailable.As of 02-dec-2020, a review of the site's complaint history cannot be conducted at this time as the site name, surgeon name, and da vinci system information remain unavailable.This complaint is being reported due to the following conclusion: during an unspecified da vinci-assisted surgical procedure, a problem allegedly occurred during surgery.Details regarding the ¿problem¿ were not provided.There is no specific allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Afterwards, the patient was placed on a ventilator in the icu.The cause of the patient¿s operative complication(s) is unknown.

Event Description

It was reported via a reply to a social media posting ("what's the nicest thing you can say to a doctor?"): "don't worry, we're not going to sue you." said by my husband to the surgeon (who was crying) while i was in icu on a vent, following a problem during surgery with the davinci robot.We loved the surgeon & my husband wanted to assure him that he knew it wasn't the surgeon's fault.¿ there is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.No further clinical information was provided.

Manufacturer Narrative

Corrected information can be found in the following fields: g3, g6, h2, h3, h6, and h10/h11.D10 ¿ a patient had initially reported through social media that they were placed on a ventilator in an icu, ¿following a problem during surgery with the davinci robot¿.The patient subsequently reported through social media posts that: 1.) ¿my bp went down to 50/30, clips on kidney had come off & i was bleeding out.Woke up 3 days later in icu on vent.¿, 2.) ¿the clips came off of my kidney causing massive bleeding into my abdomen.Went back to or where i received 4 units of blood & 13 litres of fluids.¿, and 3.) ""clips" that were supposed to hold closed the surgical site on my kidney popped off.I bled out.Big time! ended up w/ major abdominal surgery¿.As such, there is no longer any known allegation or evidence of a da vinci product issue from a qualified medical professional that would be classified as a reportable event.An unspecified clip failed after the procedure and while in recovery.The patient stated, "i had an "easy" surgery with the davinci robot to remove a possible cancerous cyst on my kidney.In recovery my bp went down to 50/30.Md made aware.Anesthesiologist said "call her husband." clips on kidney had come off & i was bleeding out.Woke up 3 days later in icu on vent.¿ there is no indication that the instrument failed since the clip was successfully placed during the procedure and there was no report of a misapplication/issue placing a clip during the procedure.Since the patient¿s bp dropped after the procedure and had to be taken back to the operating room (or), it is unlikely that the instrument malfunctioned.The clip was placed during the procedure and according to the intuitive surgical, inc.(isi) instrument & accessory user manual: the clip must be latched to ensure proper ligation of the vessel or tissue.The user should inspect the ligation site after application to ensure proper closure of the clip.Security of the closure should be confirmed after ligation.Isi is unable to conduct system or instrument log reviews due to lack of information on file at this time.No image or video clip for the reported event was submitted for review.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: PATIENT SIDE CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10989938
• MDR Text Key: 220908330
• Report Number: 2955842-2020-11338
• 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: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention