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 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the module battery box involved with this complaint and completed the device evaluation.The failure analysis was able to reproduce the reported failure.The unit failed at powering on when installed into an in-house test system.Intuitive surgical inc.(isi) also received the pca aux power board involved with this complaint and completed the device evaluation.The unit was installed onto in-house system and failure analysis was unable to reproduce the reported failure.This complaint is being reported due to a da vinci si surgical 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 during a da vinci-assisted prostatectomy procedure, the customer called in stating that they had a message for a low battery backup.The customer verified everything was plugged into wall and noted all battery status led's were green.The customer power cycled the system and as they were trying to redock, the customer received a non-recoverable error 17.They power cycled the system again with no change.The intuitive surgical, inc.(isi) technical support engineer (tse) logged into the system and noted multiple errors pointing to the patient side cart (psc).The tse had the customer try reseating the cable to the psc with no change.The tse asked the customer again to power cycle the system, switch the fiber cable to another connection and perform an emergency power off (epo) of the psc with no change.Lastly the tse had them try a second epo with no change.The surgeon elected to abort the case post anesthesia and port placement.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and was albe to reproduce the reported failure.The fse psc battery box and the auxiliary power board (apb) to resolve the issue.The apb controls the battery system in the psc.It contains the battery charger and the battery backup control which switches main system power when ac power fails.Battery box provides backup power in the event of loss of ac power to the system.This provides enough power to safely undock from the patient.

• 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: 6968891
• MDR Text Key: 90759677
• Report Number: 2955842-2017-00707
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017

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: IS3000.A60P9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1