MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM

Model Number 380990-03

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Power Problem (3010)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned to isi for failure analysis evaluation. Failure analysis confirmed that the illuminator would not ignite. The unit was installed on an in-house pca system did not ignite with in-house lamp module upon startup and system error code # 48245 was generated. This complaint is being reported due to a da vinci surgical 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 cholecystectomy procedure, a possible "spark" or "flash" was observed near the illuminator cord connection. The customer stated that a smell of smoke was then noted at the time the incident occurred. At that time, the surgeon made the decision to complete the procedure using traditional laparoscopic techniques. There was no report of any patient harm, adverse outcome or injury. An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the site. The fse found no evidence of smoke, fire or melted materials associated with the da vinci surgical system. Review of the site's system log for the reported procedure date found multiple occurrences of system error code # 48244. The fse concluded that the system error code 48244 was associated with the illuminator. To resolve the issue, the fse replaced the illuminator. The illuminator provides the light which is transported to the system endoscope and projected onto the surgical site.

Manufacturer Narrative

Additional failure analysis investigations found that the illuminator's power supply failed, thus causing the customer reported issue.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7643249
• MDR Text Key: 112566833
• Report Number: 2955842-2018-10324
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 380990-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/27/2018 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES