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

Model Number IS4000 A70.P68

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

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

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The mgps was returned for failure analysis and the reported failure was reproduced.The unit was installed and failed to power on during functional testing.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 inguinal hernia repair procedure, upon power up of the da vinci surgical system, the site heard a pop coming from the system and an unspecified non-recoverable fault was generated.The site power cycled the system and the surgeon side console (ssc) did not power on and an error message was generated indicating that the ssc was not connected to the vision side cart (vsc).The site contacted an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance and the site was instructed to cycle the ssc breaker and inspected the power outlet; however, there was no indication that the ssc had power.The site indicated to the tse that they had another da vinci surgical system; however, they were unsure if they were going to proceed with case.There was no report of any patient harm, adverse outcome or injury.Isi has made multiple follow up attempts to obtain additional information from the customer but no further details have been received.On 10-13-2017 the isi fse reported that it is believed that the site completed the planned surgical procedure with another da vinci surgical system.The isi field service engineer (fse) was dispatched to the facility and confirmed the customer reported complaint.The fse found that the power loss experienced by the site was related to the medical grade power supply (mgps).The mgps converts the ac power from the wall socket (through the power cord) and converts it to dc power for use on the system.The fse replaced the affected mgps to repair the system.

• Brand Name: DA VINCI XI 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: 6952222
• MDR Text Key: 90426172
• Report Number: 2955842-2017-00684
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• 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: 09/18/2017

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: IS4000 A70.P68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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