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

Model Number IS2000 A51P8

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

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

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc (isi) has received the high resolution stereo viewer (hrsv) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported failure.The unit was powered up and the image on left monitor consistently lost.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 eye of the high resolution stereo viewer (hrsv) in the surgeon side console (ssc) was lost with no alarm or error.The left and right images could be seen on the vision side console, however, the ssc issue persisted after power cycling.The surgeon made the decision to complete the procedure using one eye.The planned surgical procedure was completed under the conditions reported and no patient harm, adverse outcome or injury was reported.An intuitive surgical, inc.(isi) technical field specialist (tfs) was dispatched to the facility and was able to reproduce the reported issue.The ssc hrsv was replaced to resolve the issue.The hrsv provides the video image for the ssc.

• Brand Name: DA VINCI S 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: 7065560
• MDR Text Key: 93565792
• Report Number: 2955842-2017-00798
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K063220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2017

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: IS2000 A51P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• 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