MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; DA VINCI XI SURGICAL SYSTEM

Model Number IS4000

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, isi has not determined the root cause of the alleged intra-operative complication(s) sustained by the patient.Isi has attempted to contact the surgeon to obtain additional information regarding the reported event.However, as of the date of this report, no additional information has been obtained.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: while undergoing a da vinci-assisted thoracic procedure, the patient experienced bleeding after a vessel was transected between two clips that had been placed on the same vessel.In order to control the bleeding, the case was converted to open surgery.However, at this time, the root cause of the intra-operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Event Description

It was initially reported that during an unspecified da vinci-assisted thoracic procedure, an unspecified vessel began to bleed.At the time the event occurred, the surgeon was using a small clip applier instrument.Due to the bleeding, the surgeon immediately converted the surgical procedure to open surgery.On (b)(4) 2018, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: before the bleeding started, the surgeon had placed 2 clips on the vessel using a small clip applier instrument.After transecting the vessel between where the clips had been placed, bleeding was observed.The surgical staff could not control the bleeding with further coagulation attempts.As a result of the bleeding and an ¿insufflated¿ lung, the surgeon elected to convert the da vinci-assisted surgical procedure to open surgery.The csr did not know how much blood was lost and what other medical intervention was administered to the patient as a result of the intra-operative complication(s).There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

• Brand Name: DAVINCI XI
• Type of Device: DA VINCI XI SURGICAL SYSTEM
• 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: 8201375
• MDR Text Key: 131585554
• Report Number: 2955842-2018-10787
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IS4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention