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

Model Number 380675-02

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

Patient Problem Death (1802)

Event Date 09/11/2020

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, isi has not determined the root causes of the patient's post-operative death.A follow-up mdr will be submitted if any additional information is received.Isi made multiple follow-up attempts to contact the site to obtain additional information.Site history review: a review of the site's complaint history does not show any additional complaints related to this event.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.The following instruments were used in the case, none of which, other than the mega suturecut needle driver, have been used in subsequent procedures: permanent cautery hook: part number 420183 n10190701-620 was last used on (b)(6) 2020 mega suturecut needle driver: part number 420309-07 was last used on (b)(6) 2020 fenestrated bipolar forceps: part number 420250-16 n10200720-206 was last used on (b)(6) 2020.Large suturecut needle driver: part number 420296-07 n10190506-842 was last used on (b)(6) 2020.Site review does not show any additional complaints filed against any of these instruments.Failure analysis (fa) review: no fa review was conducted because no product issue was alleged.The site has also not returned any product(s).Image/video review: no images or videos were shared for the event.Medical review: a review of the event was conducted by an isi medical safety officer and the following additional information was provided: due to the timeline from surgical procedure to the patient's demise and subsequent mortality (less than 24 hours), the probable cause of death is due to a missed bowel injury, due to an attempt to perform a minimally invasive surgical procedure on a patient that had "extensive" adhesions between the bowel secondary to the seven previous inguinal hernia repairs with mesh.This complaint is being reported due to the following conclusion: it was reported that a caucasian female in her 50's who underwent a da vinci-assisted inguinal hernia repair surgical procedure sustained a bowel injury.The patient reportedly expired the following day.At this time, the cause of the patient's demise is unknown.Although it was confirmed through product review that there are no indications of a malfunction of a da vinci system, instrument, or accessory; isi has not been able to obtain additional details from the site regarding the reported incident as of the date of this report.

Event Description

It was reported that a caucasian female in her 50's who underwent a da vinci-assisted inguinal hernia repair surgical procedure sustained a bowel injury.The patient reportedly expired the following day.However, at this time, the cause of the patient's demise is unknown.On 18-sept-2020, intuitive surgical, inc.(isi) contacted the isi clinical territory associate (cta) and obtained the following information.The cta stated she was present during an attempted da vinci-assisted inguinal hernia repair surgical procedure.The patient had undergone seven previous inguinal hernia repairs in the same location with the placement of mesh.None of the previous repairs were performed robotically.On (b)(6) 2020, it was the eighth procedure, and the first robotic procedure, for the hernia repair.The surgeon encountered "extensive adhesions" between the bowel and the region of the previous seven hernia repairs during the procedure.The surgeon used a permanent cautery hook (pch) instrument to release the bowel from the previous inguinal hernia repair region.During the release of the adhesion, the surgeon injured both the small bowel and ascending colon a "few times." the surgeon placed "sutures" to repair the bowel injuries.The surgeon stopped the procedure after the bowel was injured during the adhesiolysis and subsequent repair.The surgeon did not want to remove the old mesh and place new mesh due to the abdominal cavity contamination from the bowel injuries.The surgeon planned to place the patient on antibiotics and reschedule the robotic procedure in a "week" to complete the procedure.The patient expired on (b)(6) 2020.However, at this time, the cause of the patient's demise is unknown.The cta confirmed there were no reports of a malfunction of a da vinci system, instrument, or accessory.The cta confirmed there was no video recording of the procedure.On (b)(6) 020, the cta confirmed that the surgeon had completed the adhesions' release between the bowel and previous hernia repairs.The cta also confirmed that the surgeon did run the bowel to check for additional bowel injuries.The cta was unable to obtain details of the death certificate and/or autopsy results.Isi made multiple follow-up attempts to contact the site to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM, RECERTIFIED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10690130
• MDR Text Key: 211853388
• Report Number: 2955842-2020-11084
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380675-02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death