MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-09

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the hrsv monitor involved with this complaint and completed the device evaluation.Failure analysis found that the hrsv monitor does not turn on.The unit power and ic caps were repaired/replaced.Also, the unit was cleaned, calibrated and tested.The 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 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 was missing from the surgeon side console (ssc).The intuitive surgical inc.(isi) technical support engineer (tse) instructed the site to perform a restart and hard restart of the system but the issue could not be resolved.The surgeon decided to use another ssc from another system to complete the case.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the site to further investigate the reported complaint.The fse confirmed the reported issue and replaced left high resolution stereo viewer (hrsv) monitor.The hrsv is located on the surgeon side console and provides the 3d image captured from the endoscope inserted in the patient.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7421709
• MDR Text Key: 105523898
• Report Number: 2955842-2018-10126
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

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: 380610-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2009
• 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