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

Model Number 380990-11

Device Problem Poor Quality Image (1408)

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

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc (isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis was unable to confirm the reported failure.A visual inspection was performed and the front ventilation was found to have debris stuck on it.The unit was installed into pca system and a power cycle was performed and no error had occurred.A white balance laser check was completed and it was good.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 inguinal hernia procedure, the customer was getting a red hue when the illuminator was turned on.The customer had tried multiple endoscopes and tried power cycling the system but the red hue was still present.The customer indicated that when the illuminator was off, the image had a green hue to it.The intuitive surgical, inc.(isi) technical support engineer (tse) had the customer perform a hard cycle on the vision side cart (vsc) and to check the camera cable while the system was off but the system powered back on with the same issue.Further troubleshooting was performed but the issue could not be resolved.At that time, 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.

• Brand Name: DA VINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7826034
• MDR Text Key: 118752630
• Report Number: 2955842-2018-10493
• 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
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• 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: 08/21/2018
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• 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