FDA Adverse Event Malfunction Summary report: N

HARMONIC CURVED SHEARS INSERT ACCESSORY

MDR report key: 1791622 · Received July 29, 2010

Report

Report Number: 2955842-2010-00346
Event Type: Malfunction
Date Received: July 29, 2010
Date of Event: June 29, 2010
Report Date: June 29, 2010
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: NAY
PMA / PMN Number: K042855
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE INSERT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE CLAMP ARM WAS BROKEN OFF AND ONE SIDE OF THE HINGE FEATURE THAT ACCEPTS THE CLAMP ARM PIN IS BENT. THE EVIDENCE IS NOT CONCLUSIVE, HOWEVER, THE DAMAGE IS CONSISTENT WITH HYPEREXTENSION OF THE CLAMP ARM. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NO 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 ASSISTED CYSTECTOMY PROCEDURE, THE TIP OF THE HARMONIC CURVED SHEARS INSERT ACCESSORY BROKE OFF AND FELL INTO THE PATIENT. THE LOCATION OF THE BROKEN PIECE WAS IDENTIFIED VIA X-RAY AND THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED DURING THE OPEN SURGICAL PROCEDURE PORTION OF THE PLANNED CASE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONIC CURVED SHEARS INSERT ACCESSORY	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL, INC.	400169-07

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR			ESU\| HCS INSTRUMENT\| DA VINCI S SYSTEM & ACCS