MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-46

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/03/2020

Event Type  Death  

Manufacturer Narrative

Based on the information provided the cause of the reported death is unknown.If additional information is received a follow-up mdr will be submitted.Isi has made additional attempts to contact the site and gather patient information.However, no new information has been obtained from the site as of the date of this report.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2020.No related system errors were found to have occurred during the surgical procedure.All the instruments that were used during the procedure were subsequently used in other procedure(s) with the exception of a fenestrated bipolar a forceps and cadiere forceps.Based on a site history query there are no complaints alleged against the instruments used during the procedure.No images or videos were available for review, and no product was returned for analysis because no product issue was alleged.Although there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, based on the information available, the complaint is being reported due to the following conclusion: isi was not able to obtain further details regarding the post-operative complication and subsequent death and whether they were related to the device.Implant date is not applicable because the product is not implantable.

Event Description

It was reported that, on (b)(6) 2020, two days post a da vinci-assisted total hysterectomy that was completed robotically without any reported complications, the patient returned to the hospital emergency room (er) presenting symptoms of bilateral pneumonia.The patient expired the following day, (b)(6) 2020.The cause of death is unknown at this time.On (b)(6) 2020, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: the patient was a (b)(6) year old white female who underwent a total benign hysterectomy procedure of (b)(6) 2020, with no reported complications.The patient did not require any unplanned medical or surgical intervention during the procedure, and was reported as doing well.On post-operative day #2, (b)(6) 2020, the patient reported to the er with unspecified symptoms and was diagnosed with bilateral pneumonia.It was reported that the patient subsequently expired on (b)(6) 2020.Although, initially it was relayed that the cause of death was potentially related to covid-19, the csr has made additional attempts to contact the site and gather information.However, no new information has been obtained from the site as of the date of this report.Therefore, the cause of death is inconclusive at this time.There was no allegation of any system, instrument or accessory malfunction during the procedure.

Event Description

Refer to h10/h11 for additional information.

Manufacturer Narrative

Updated fields: additional information on a2, a4, b6, b7, g7, and h2.G4 updated with the date intuitive surgical, inc.(isi) received the information.Correction: e4 - initial reporter sent to fda new additional information: on (b)(6)2020 , isi received additional information from the surgeon.Patient demographics, patient's medical history, and relevant tests performed.The surgeon had also stated that covid-19 is the suspected cause of death, as there was not a cause of death determined by autopsy.The surgeon also stated that there was no malfunction of a da vinci system, instrument or accessory, and that the procedure was completed robotically.Based on the additional information received, the cause of death was not determined by autopsy.However, the suspicion of covid-19 as a potential cause remains.No isi product malfunction was alleged.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9919438
• MDR Text Key: 186266389
• Report Number: 2955842-2020-10269
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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: 380652-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• 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): Death
• Patient Age: 36 YR
• Patient Weight: 94