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

Model Number 380652-31

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

Patient Problems Septic Shock (2068); Hernia (2240)

Event Date 02/24/2021

Event Type  Death  

Manufacturer Narrative

This is event is being reported because the patient of a da vinci-assisted surgical procedure returned to the hospital for an unexpected follow-up procedure, and ultimately expired of septic shock.It is currently unknown how the da vinci system and products contributed, if at all, to the reported adverse event.A review of the event was conducted by an isi medical safety officer and the following information was provided: "based upon the information provided in the above section, it is unclear how the da vinci system, instrumentation, and/or accessories may have caused or contributed to internal hernia at the mesenteric defect of the jejunojejunostomy.It is additionally unclear from the information above if the bowel was perforated and when the bowel was perforated." the instrument logs were pulled for all instruments used during this procedure.The endoscope, fenestrated bipolar forceps, cadiere forceps, and mega suturecut needle driver were all used in subsequent procedures.The vessel sealer extend and sureform 60 stapler are both single use instruments.The monopolar curved scissors instrument has not been used in a subsequent procedure and has 2 uses remaining.There are no complaints created for the any of the instruments used during this procedure.The system error logs were pulled and no relevant system errors were noticed during this procedure.A review of the sureform 60 stapler logs for the reported procedure was conducted by a senior failure analysis engineer and the following information was provided: "this instrument fired qty 6 reloads (5 blue followed by 1 white).All firings were completed per the logs.First 5 firings (blue) did not have any pauses for compression.The last firing (white) did have 1 pause during the firing.There were no incomplete clamps in the procedure." this is event is being reported because the patient of a da vinci-assisted surgical procedure returned to the hospital for an unexpected follow-up procedure, and ultimately expired of septic shock.It is currently unknown how the da vinci system and products contributed, if at all, to the reported adverse event.

Event Description

It was initially reported that after a da vinci assisted gastric bypass procedure, the patient expired.It was discovered that the patient had a perforated bowel and went septic.The surgeon added that he thought if the procedure was done laparoscopically, the patient injury may not have occurred.Follow-up: on 29-apr-2021, intuitive surgical inc.(isi) contacted the surgeon of this procedure and additional information was obtained about the event: the da vinci gastric bypass procedure was on (b)(6) 2021.The surgeon said the procedure went fine and there were no observed malfunctions of da vinci products.The patient returned to the hospital two to three days after the da vinci procedure.An open procedure was performed to resolve an internal hernia through the small bowel mesentery closure at the jejunostomy.The surgeon reported a v-lock suture was used on this hernia during the initial da vinci procedure, but that the v-lock suture came undone.The surgeon said he was concerned the v-lock suture was too rough for the fragile tissue it was used on.The surgeon also said he has started using silk sutures instead of v-lock.The surgeon said this hernia was resolved and the patient got better.However, approximately two to three days after the open procedure (exact date unknown), the patient was discovered to have passed away.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11897997
• MDR Text Key: 253059360
• Report Number: 2955842-2021-10567
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-31
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• 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