MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI S; PATIENT SIDE CART, 4-ARM

Model Number 380430-03

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

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) has been requested to investigate the reported event.At this time, the additional isi fse investigation has not been completed, therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted 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 customer experienced a non-recoverable error 25515 pointing to an intermittent problem on internal cable harness issue.The intuitive surgical, inc.(isi) technical support engineer (tse) completed troubleshooting; however, the issue persisted.The site converted and completed the procedure using laparoscopic surgical techniques.There was no report of patient harm, adverse outcome or injury.

Manufacturer Narrative

A field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.The fse was able to confirm the reported issue in the system logs and thus replaced the set up joint (suj ) to resolve the issue.The suj allows for the positioning of the system's manipulators.The replaced part has not been received by isi for evaluation; therefore the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the unit is returned or if any additional information is received.

• Brand Name: DAVINCI S
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7426740
• MDR Text Key: 105761266
• Report Number: 2955842-2018-10133
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K063220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380430-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES