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); Defective Component (2292); Device Operates Differently Than Expected (2913)

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

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc (isi) received this device involved with this complaint and completed the device evaluation.Failure analysis installed this unit into the printed circuit assembly (pca) test system and it failed to power on the core of the vision side cart (vsc).Failure analysis applied power to the power tray at the test bench and found that power supply a was dead.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 malfunctioned 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 boom system would not power up.The intuitive surgical inc.(isi) technical support engineer (tse) had the site check the core power switch was on but there was no power to the core.The customer checked all power cords and switches but the issue persisted.The isi clinical sales representative (csr) called back and stated that the site had to bring in another core and illuminator from another tower to continue and complete the procedure with no further issues.There was no report of patient harm, adverse outcome, or injury.Isi followed up and obtained the following additional information: the csr stated the system was working at the start of the procedure but the issue occurred in the middle of the procedure.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.The fse found no issues with the illuminator, however, since the core lost power, it causes the illuminator to shut off.To resolve the issue, the fse replaced the power tray assembly core and the system powered up.

• 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: 6884419
• MDR Text Key: 88253831
• Report Number: 2955842-2017-00623
• 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: 08/28/2017

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: 09/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• 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