FDA Adverse Event Malfunction Summary report: N

DA VINCI SI SURGICAL SYSTEM

MDR report key: 4243386 · Received November 11, 2014

Report

Report Number: 2955842-2014-05649
Event Type: Malfunction
Date Received: November 11, 2014
Date of Event: October 8, 2014
Report Date: October 14, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K081137
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

INTUITIVE SURGICAL INC. (ISI) RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE REPORTED ISSUE WITH THE AXIS BRAKE. THE PSM FAILED THE WEIGHTED BRAKE DROP TEST. THE BRAKE FAILURE IS DIRECTLY RELATED TO THE REPORTED ERROR CODE 23022. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS. ALTHOUGH THIS WAS FOUND IN THE SITE'S SYSTEM LOGS, THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

Description of Event or Problem · 1

AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER WAS REVIEWING THE SITE'S SYSTEM LOGS AND NOTICED MULTIPLE SYSTEM ERROR CODE 23002 ON AXIS 2 OF PATIENT SIDE MANIPULATOR (PSM). AN ERROR CODE 23022 IS A RECOVERABLE BRAKE TEST ERROR. A SYSTEM ERROR CODE 23022 APPEARS WHEN THE DA VINCI SAFETY SYSTEM DETECTS TOO MUCH MOTION WHILE TESTING THE MECHANICAL BRAKES IN THE PATIENT SIDE MANIPULATOR DURING STARTUP. THE PSM IS AN INSTRUMENT ARM WHICH IS LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE PSM WAS REPLACED. THERE WAS NO REPORTS OF PATIENT INVOLVEMENT OR ANY INDICATION THAT AN ADVERSE EVENT OCCURRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
725593	DA VINCI SI SURGICAL SYSTEM	ENDOSCOPIC INSTRUMENT CONTROL SYSTEM	NAY	INTUITIVE SURGICAL,INC.	IS3000 A6.0P8

Patients

Seq	Age	Sex	Outcome	Treatment
1