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

Model Number IS3000 A60P9B

Device Problems Electrical /Electronic Property Problem (1198); No Device Output (1435); Device Displays Incorrect Message (2591)

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

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint and completed the device evaluation.Failure analysis investigation was able to reproduce the customer reported failure mode.Visual inspection found one bad fuse and dusty fans.The illuminator was installed and tested on an in-house test system and failed to power on with errors 297/48238.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 gastrectomy procedure; the intuitive surgical, inc.(isi) clinical sales representative (csr) experienced a non-recoverable error 297 and the illuminator went down and did not turn back on.The surgeon made the decision to complete the procedure using an external light source.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.An isi technical field specialist (tfs) was dispatched to the facility and was able to reproduce the issue and verified the error code in the log files.The illuminator was replaced to resolve the issue.The illuminator contains a high-intensity light source to illuminate the surgical site and the electronics for initial processing of endoscopic video.

• 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: 6867409
• MDR Text Key: 86419853
• Report Number: 2955842-2017-00608
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

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: 09/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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