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

Model Number IS3000 A60P9B

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

The mtm was returned for failure analysis and the reported failure (error 1) was able to be reproduced during calibration (via matlab).Corrosion was found on several of the pca boards and ffcs in the gimbal.The mtm was repaired with replacement parts.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2017.The system logs reveal that approximately 1.5 hours before the surgical procedure was started, a system error code 1 was generated by the system.The system error code 1 was generated after the system detected a low power supply voltage on the mtml board.The site disabled the mtml and recovered from the fault.When the surgeon attempted to use the system about 1.5 hours later, he complained that mtml was not working.At that point, the site likely contacted the tse for assistance.The site rebooted the system two times while troubleshooting but came across additional system error codes 1 and 2.A system error 2 is also generated when a low reference voltage is out of range.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the left arm on the patient side cart (psc) was not working.The surgical staff contacted an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance.The tse logged into the site's system logs and found errors pointing to the left master tool manipulator (mtml).The master tool manipulator (mtm) refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console.One mtm is assigned to the surgeon's left hand (mtml) and one to his right (mtmr).Per the request of the tse, the site restarted the da vinci surgical system and reset the breaker two times.The reported issue could not be resolved with troubleshooting and the surgeon made the decision to convert the surgical procedure to traditional laparoscopic surgery.There was no allegation that the patient was harmed due to the customer reported issue.On 11/30/2017, an isi field service engineer (fse) performed a field evaluation at the site.The fse replaced the mtml to resolve the customer reported issue.The fse then tested the system and verified that it was ready for use.On 12/19/2017, isi obtained the following additional information regarding the reported event from the isi clinical sales representative (csr).The surgical procedure was completed successfully via traditional laparoscopic surgery.No post-operative complications have been reported.In addition, there have been no recurrences of the customer reported issue at the site.

Manufacturer Narrative

Intuitive surgical, inc.(isi) performed additional analysis of the master tool manipulator (mtm) that was returned for evaluation.The mtm failed a friction test on axis 6.The axis 6 motor was replaced.Based on the current information provided, this complaint will remain reportable due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.

• Brand Name: DA VINCI SI 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: 7136502
• MDR Text Key: 96051752
• Report Number: 2955842-2017-00859
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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