MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI S; VISION SIDE CART, HD, DOMESTIC

Model Number 380453-51

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

The fse resolved the issue by serviced the main board in the illuminator.No parts were replaced, therefore, nothing will be returned to isi for evaluation.If additional information is received a follow up mdr will be submitted.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 wouldn't start up.The intuitive surgical, inc.(isi) technical support engineer (tse) attempted troubleshooting but the issue persisted.The procedure was completed using an alternate light source.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 confirm the reported failure.The fse serviced the main board in the illuminator to resolve the issue.

• Brand Name: DAVINCI S
• Type of Device: VISION SIDE CART, HD, DOMESTIC
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7293004
• MDR Text Key: 101009792
• Report Number: 2955842-2018-10016
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380453-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2011
• 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