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

Model Number 380601-40

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

Patient Problem Insufficient Information (4580)

Event Date 03/29/2022

Event Type  Death  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.A review of the system logs for the procedure date of (b)(6) 2022 has been performed by a technical support engineer (tse) and the following was observed: no relevant errors were observed during this procedure.As of this review, the customer site has used this system to perform one procedure since this customer reported event.No relevant errors were noticed during this subsequent procedure.A field service engineer (fse) was dispatched to the site to retrieve the system logs for this customer reported event (see (b)(4)).The fse performed system verification testing and confirmed there are no issues with the system.The system is operational and verified ready for use.A review of the instrument logs has been performed for this procedure and the following was observed: all multi-use instruments used in the case have been used in subsequent procedures with the exception of the single-use instruments and the following instruments: endoscope (part number: 430060-41 / lot number: 001001-2241 / uses remaining: 15), cadiere forceps (part number: 430009-52 / lot number: s10210108-0004 / uses remaining: 15), maryland bipolar forceps (part number: 430010-52 / lot number: s11210831-0019 / uses remaining: 16), both medium-large clip appliers (part number: 430005-52 / lot number: s10210819-0002 / uses remaining: 141) and (part number: 430005-52 / lot number: s10200814-0007 / uses remaining: 41).A site history review shows no complaints have been created for any of these instruments.This event is being reported due to the following conclusion: it was reported that during a da vinci-assisted prostatectomy with lymphadenectomy procedure that the patient experienced a cardiac event and passed away.

Event Description

It was reported that during a da vinci-assisted prostatectomy with lymphadenectomy procedure that the patient's lung capacity started to deteriorate.The patient then experienced an unspecified cardiac event and coded.The da vinci system was undocked from the patient to attempt to revive the patient, but the attempts were unsuccessful.The patient reportedly expired in the operating room.On 31-mar-2022, an intuitive surgical inc.(isi) enterprise solutions manager (esm) was contacted and additional information was obtained on this event: the esm was present for the first 45 minutes of this procedure.The procedure was going well with no issues.The esm left the operating room for 65 minutes as they went to call into a conference call for another event.When the esm returned to the operating room he noticed a crowd of people around the operating room.The esm observed the patient undocked with their port sites being sutured as if the procedure was completed.The esm encountered the surgeon leaving the operating room and asked what happened.The surgeon said the patient coded and that they did everything they could before walking away.The esm asked the operating room staff still in the area what had occurred and the esm was informed of the information they reported to create this complaint including that the patient had expired.No further communication regarding this event has been had with this esm.On 14-apr-2022, an isi esm was informed by the surgeon of this procedure that the surgeon was instructed by the site's risk management department not to discuss this event.

Manufacturer Narrative

On 02-may-2022, a medical review of the event information was performed by an intuitive surgical inc.(isi) medical safety officer and the following information was provided: based upon the information in the description of events above, i am unable to determine the extent of the contribution or cause of the events that might have led to the patient¿s death during a da vinci-assisted prostatectomy with lymphadenectomy.

• Brand Name: DA VINCI SP
• Type of Device: PATIENT SIDE CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14247706
• MDR Text Key: 290364583
• Report Number: 2955842-2022-11324
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380601-40
• Device Catalogue Number: 380601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Male