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

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

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The illuminator was installed into a test system and it failed to power on with error 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 total benign hysterectomy procedure, the customer received an error 48238 and the illuminator lamp would not turn on.The intuitive surgical, inc.(isi) technical support engineer (tse) attempted to troubleshoot but the issue persisted and advised the customer to use a third party illuminator to continue the procedure.The planned surgical procedure was completed with an alternate light source and no patient harm, adverse outcome or injury was reported.An isi field service engineer (fse) was dispatched to the facility and replaced the illuminator to resolve the issue.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: 6996300
• MDR Text Key: 91533765
• Report Number: 2955842-2017-00727
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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: 10/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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