FDA Adverse Event Malfunction Summary report: N

MEGA NEEDLE DRIVER INSTRUMENT

MDR report key: 2842787 · Received November 21, 2012

Report

Report Number: 2955842-2012-01033
Event Type: Malfunction
Date Received: November 21, 2012
Date of Event: October 25, 2012
Report Date: October 25, 2012
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE INSTRUMENT WAS FOUND WITH THE CARBIDE INSERT BROKEN OFF THE GRIP JAW. SLIGHT DAMAGE WAS FOUND ON THE EDGE OF THE JAW TIP. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

Description of Event or Problem · 1

IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE MEGA NEEDLE DRIVER INSTRUMENT HAD A MISSING GRIP ON THE TIP PORTION OF THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MEGA NEEDLE DRIVER INSTRUMENT	ENDOSCOPIC INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420194-08	M10110328 851

Patients

Seq	Age	Sex	Outcome	Treatment
1				DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES