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

Model Number IS3000.A60P9B

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc (isi) received this device involved with this complaint and completed the device evaluation.Failure analysis installed this unit into the printed circuit assembly (pca) test system and it failed with the reported error.The sal board will be replaced to correct the audio issue 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 malfunctioned were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-ssisted partial nephrectomy procedure, the customer kept receiving an audio error.The site attempted to troubleshoot the issue by rebooting the system and removing all audio devices with no success.An intuitive surgical, inc.(isi) technical support engineer (tse) instructed the site to remove the instruments, power the system off, and cycle the breakers on the vision side cart (vsc) and the surgeon side console (ssc) with no change.The site once again rebooted along with re-seating the blue fiber cable with no change.At that time the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.Isi made multiple follow up attempts to gather additional information, however, no additional details have been received as of date of this report.An isi technical field specialist (tfs) was dispatched to the facility and was able to reproduce and the reported failure and confirm the error in the system logs.The tfs repalced the personality module surgeon console (pmsc) to resolve the error.The pmsc is a module that consists of 5 interface boards.

• 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: 7044965
• MDR Text Key: 93173163
• Report Number: 2955842-2017-00780
• 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: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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: 11/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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