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

Model Number IS2000 A51P8

Device Problems Electrical /Electronic Property Problem (1198); No Device Output (1435)

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

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

The illuminator has not been returned to isi for evaluation therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.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 surgical procedure; the illuminator blacked out with no errors.An intuitive surgical, inc.(isi) technical field specialist (tfs) provided troubleshooting but the issue persisted.The surgeon made the decision to complete the procedure using an external illuminator.There was no report of patient harm, adverse outcome or injury.A technical field specialist (tfs) was dispatched to the facility and was able to reproduce the issue.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.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the illuminator for evaluation.Failure analysis investigation was able to reproduce the customer reported failure mode.Visual inspection found the fuses were good and the fan was dusty.The unit was installed and tested on an in-house test system and failed to power on.

• Brand Name: DA VINCI S 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: 6896134
• MDR Text Key: 87880864
• Report Number: 2955842-2017-00631
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K063220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2017

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: IS2000 A51P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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