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 Problems Death (1802); Embolism (1829)

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the cause of the air embolism and patient death are unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.The following information is also unknown: the type of da vinci-assisted urological procedure that was performed, the date the surgical procedure was performed, when the air embolism was identified, what medical intervention was administered due to the air embolism, and what date the patient expired.A review of the site¿s system logs related to the da vinci-assisted surgical procedure in question cannot be performed since the event date is unknown.This complaint is being reported due to the following conclusion: a patient underwent an unspecified da vinci-assisted urological procedure and allegedly expired from an air embolism related to the use of an air seal device (a 3rd-party manufacturer device).There is no allegation that a malfunction of a da vinci surgical system occurred.Blank mdr fields: follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.Field implant date is not applicable because the product is not implantable.

Event Description

It was reported by a professor of respiratory surgery that a patient underwent an unspecified urological da vinci-assisted surgical procedure on an unspecified date.The professor indicated that the patient died from an air embolism as a result of using an air seal (a 3rd party manufacturer device) by increasing the pressure to increase the hemostatic effect.On 12-mar-2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the isi clinical sales representative (csr) reportedly heard that the respiratory surgeon had conducted the da vinci-assisted urological procedure.The surgical procedure was recorded on video.However, it is unknown if the video is available for isi to review.There were no reported intra-operative complications.No further clinical or patient information was provided.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Manufacturer Narrative

Updated information can be found in the following fields: g4, g7, h2, and h10/11.Corrected information can be found in the following field: h10/11.H10/11 should have noted the following on the initial mdr submission: sections g5 (510k #) and h4 (device manufacture date) are not available due to insufficient product information.

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: 9923319
• MDR Text Key: 186513814
• Report Number: 2955842-2020-10273
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Death; Life Threatening