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

Model Number IS3000.A60P9B

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc (isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis was not able to reproduce the reported failure.However, the error code was confirmed via error logs.The error log displayed illuminator err lamp ignite fail.The illuminator was installed on an in-house system and powered up in normal mode with no errors.It passed communication, video, white balance, auto 3d calibration, and ten power cycles without any issue.This complaint is being reported due to a da vinci surgical 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 illuminator failed with an error code 48345 and displayed error code 100.The illuminator displayed error code 100.The intuitive surgical, inc.(isi) technical support engineer (tse) advised the customer to get an auxiliary illuminator to complete the procedure.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and he confirmed multiple errors 48345 in the error logs.The fse replaced the illuminator to resolve the issue.The illuminator provides the lighting for the surgical field.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.

• 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: 6871325
• MDR Text Key: 87205659
• Report Number: 2955842-2017-00611
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• 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: 09/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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