MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS4000 A70P6

Device Problem Device Issue (2379)

Patient Problem Injury (2348)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, isi has not determined the root cause for the alleged post-operative complication experienced by the patient.Isi has attempted to contact the surgeon and site to obtain additional information concerning the reported event; however, no additional information has been provided as of the date of this report.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) 2017.No related system errors were found to have occurred during the single-site da vinci-assisted surgical procedure.This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient was found to have a bile leak.However, at this time, the root cause of the post-operative complication is unknown.

Event Description

It was initially reported that during a single-site da vinci-assisted cholecystectomy procedure performed on (b)(6) 2017, the surgeon experienced a lot of resistance with instrument movement.On 02/07/2017, an intuitive surgical, inc.(isi) field service engineer (fse) performed a field evaluation at the site.The fse was unable to replicate the customer reported failure mode.The fse tested the da vinci surgical system and verified that the system was ready for use.During the field evaluation, the fse reportedly spoke to the site's robotics coordinator regarding the reported event.The robotics coordinator claimed that due to resistance with the universal surgical manipulator (usm) and restricted motion, the surgeon had to target below the anatomy.The robotics coordinator claimed that there was limited spacing and movement.On 02/09/2017, the isi clinical sales representative (csr) indicated that the patient came back to the hospital with a post-operative bile leak and was going through unspecified testing.The csr indicated that the surgeon performed two subsequent da vinci-assisted surgical procedures the day the reported event occurred and there were no reported issues during either procedure.

• Brand Name: DA VINCI XI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6549339
• MDR Text Key: 74584137
• Report Number: 2955842-2017-00279
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IS4000 A70P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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