FDA Adverse Event Malfunction Summary report: N

5MM MARYLAND DISSECTOR INSTRUMENT

MDR report key: 2853175 · Received July 18, 2008

Report

Report Number: 2955842-2008-01161
Event Type: Malfunction
Date Received: July 18, 2008
Report Date: July 18, 2008
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: NAY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE REPORTED COMPLAINT, ENGINEERING CONFIRMED THAT THE MAIN TUBE HAS A COUPLE OF DIFFERENT DAMAGED SECTIONS WITH TUBE INSULATION REMOVED. THE DAMAGED AREAS ARE LOCATED ROUGHLY 0.7 INCHES AND 1.7 INCHES ABOVE THE SNAKE WRIST. THE TUBE INSULATION APPEARS TO HAVE SCRATCHES AND GOUGE MARKS. THE LOCATION AND APPEARANCE OF THE DAMAGE INDICATES THAT IT WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS AND REMOVAL FROM THE CANNULA ACCESSORY MAY HAVE EXACERBATED THE DAMAGE. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS; DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A DA VINCI S THYROIDECTOMY PROCEDURE DAMAGES ON THE 5MM MARYLAND DISSECTOR INSTRUMENT WERE OBSERVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	5MM MARYLAND DISSECTOR INSTRUMENT	ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL, INC.	420143-04	0803201 044

Patients

Seq	Age	Sex	Outcome	Treatment
1				ELECTROSURGICAL UNIT\| ACCESSORIES\| DA VINCI S SURGICAL SYSTEM