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

Model Number IS3000 A60P9B

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

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

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) has received the units involved with the this complaint, however, the device evaluations are still in progress and have not been completed.A follow-up mdr will be submitted once the device evaluations have been completed or if additional information is received.This complaint is being reported due 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 the reported 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 in the surgeon side console (ssc) was out.The customer restarted the system but the problem persisted.The intuitive surgical, inc.(isi) technical support engineer (tse) instructed the customer to check the left eye via the vision side cart (vsc) touchscreen and it was good.The tse had the customer restart the system again and nothing displayed in left monitor in console.The surgeon made the decision to complete the procedure without having visibility in the left eye of the ssc.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.To resolve the issue, the fse replaced the personality module surgeon console (pmsc) and high resolution strero viewer (hrsv).The hrsv provides the video image for the ssc.The pmsc is a module that consists of 5 interface boards.

Manufacturer Narrative

Additional information can be found with this complaint and completed the device evaluations.The investigation results are as follows: failure analysis (fa) was able to reproduce the reported complaint on the patient side manipulator during the cine cycle.Fa found the video in the high resolution stereo viewer to be lost intermittently.Fa was not able to reproduce the reported complaint on the personality module surgeon console.The unit was installed on the pca test system.It started up with no error.The video in both right and left eyes were sharp and clear.Performed ten power cycles and system came up with a good image in both eyes.The module passed the system test and no trouble was found.This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical, or intuitive surgical employees, caused or contributed to the reportable 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: 6648832
• MDR Text Key: 77842548
• Report Number: 2955842-2017-00374
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

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: 05/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• 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