MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

Patient Problem Blood Loss (2597)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Isi has not received the vse instrument involved with the reported event.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2018.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: during the da vinci-assisted lar procedure, the vse instrument allegedly failed to adequately seal the ima.In order to control bleeding, the case was converted to open surgery.

Event Description

It was reported that during the da vinci-assisted low anterior resection (lar) procedure, the sealing function of a vessel sealer extend (vse) instrument was allegedly not working.Prior to contacting an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance, the surgeon had elected to convert to open surgery.The tse reportedly reviewed the site¿s system logs and did not identify any related system faults.On (b)(4) 2018, isi contacted the isi specialty sales manager (ssm) and obtained the following additional information regarding the reported event: the ssm was present during the da vinci-assisted lar procedure which was not recorded on video.During the case and before the alleged event occurred, the surgeon was able to seal with the vse on mesentery.The vse instrument allegedly failed to adequately seal the inferior mesenteric artery (ima).While attempting to seal the ima, the ssm and surgical staff heard the audible tones indicating that the sealing cycle was complete.The surgical staff saw tissue effect while the ima was being sealed with the vse.There were no system errors when the event occurred.The ima was less than 7mm in diameter and the ssm could not recall seeing evidence of vessel calcification.The seals reportedly collapsed and the patient experienced a blood loss of approximately 200-300 ml.Blood had reportedly squirted on the lens of the endoscope multiple times but the surgical staff reportedly cleaned the lens at least two times.The surgeon could not control the bleeding with the vse and therefore made the decision to convert to open surgery via a hand-assist port.The surgeon was able to control the bleeding through the hand-assist port and the surgical procedure was completed successfully.

• Brand Name: DAVINCI
• Type of Device: VESSEL SEALER EXTEND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: pat flanagan ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8203692
• MDR Text Key: 131703406
• Report Number: 2955842-2018-10791
• Device Sequence Number: 1
• Product Code: NAY
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Lot Number: T10180713 0074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention