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

Model Number 380990-11

Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the illuminator associated with this complaint and completed the device evaluation.Failure analysis was able to reproduce the reported failure.Visual inspection found the front ventilation window with a lot of dirt.The unit was then installed on a test system and it failed the white balance test.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 it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, the customer experience white balance calibration failures.The intuitive surgical, inc.(isi) technical support engineer (tse) had the customer power cycle the system, verify the light cable was fully seated, confirm that fluorescence was off and restore factory default settings but the issue persisted.The customer then installed light guide into an alternate light source and white balance calibration passed.However, the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.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 confirm the customer reported failure.To resolve the issue, the fse replaced the illuminator.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• 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: 7585226
• MDR Text Key: 110575865
• Report Number: 2955842-2018-10277
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

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: 380990-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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