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

Model Number A60P9B IS3000

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint and completed the device evaluation.The failure analysis was unable to confirm the customer reported failure.Visual inspection was performed and the unit was still in good condition.The unit was installed into pca system and a power cycle was performed with no issues.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 light was not turning on.The site swapped to an alternate light source and continued with 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 was able to reproduce the reported problem.The fse removed and replaced the illuminator due to numerous 48244 and 48245 ignition circuit errors.The illuminator contains a high-intensity light source in order 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: 6884220
• MDR Text Key: 87338904
• Report Number: 2955842-2017-00622
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/30/2017

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: A60P9B IS3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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