MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-13

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

The root cause of the reported intra-operative complication cannot be determined.A follow-up mdr will be submitted if any additional information is received.The site's system logs were reviewed with a procedure date of (b)(6) 2018, error 23075 was identified pointing to the right gimbal, indicating that it possibly moved without the surgeon's hands on the grip, possibly user induced.An isi field service engineer (fse) visited the site and performed a system verification.The fse performed gravity calibration and tested both the right and left mtms.There was no trouble found.There was no part replacement, and the system was tested and verified for use.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted surgical procedure, the right mtm moved on its own while the surgeon was gripping it.The permanent cautery hook instrument that was installed in that arm went into the liver bed of the patient.The surgeon was able to cauterize the liver bed and continue with the procedure.The root cause of the reported injury is unknown at this time.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the right master tool manipulator (mtm) moved on its own while the surgeon was gripping it.The permanent cautery hook instrument was installed on the arm that was controlled with the right mtm which went into the bed of the patient¿s liver.The liver injury was cauterized to resolve the issue.On 19-dec ¿ 2018, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following information regarding the reported event: it was reported that during a da vinci-assisted cholecystectomy surgical procedure, the right mtm moved on its own while the surgeon was gripping it.The permanent cautery hook instrument was installed in that arm.The surgeon stated that the energy on the permanent cautery hook instrument was not activated, then the bedside assist noted that the instrument was not connected to the instrument¿s energy cord.The csr stated that the nurse connected the instrument energy cord while the permanent cautery hook instrument was still inside the patient.At that time, the arm with the permanent cautery hook instrument moved and the instrument tip went into the patient¿s liver bed.The surgeon reportedly cauterized the liver with the permanent cautery hook instrument to repair the injury.The procedure was completed with no further issues.There were no post-operative complications reported.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 8219688
• MDR Text Key: 132203316
• Report Number: 2955842-2018-10813
• 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: 12/13/2018

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: 380677-13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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