FDA Adverse Event Malfunction Summary report: N

HARMONIC CURVED SHEARS INSERT

MDR report key: 1942604 · Received December 30, 2010

Report

Report Number: 2955842-2010-00565
Event Type: Malfunction
Date Received: December 30, 2010
Date of Event: November 10, 2010
Report Date: December 1, 2010
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K011281
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

THE INSERT ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THAT THE CLAMP ARM DETACHED FROM THE DISTAL END. ONE SIDE OF THE SHAFT FEATURE THAT MATES WITH CLAMP ARM PINS IS BENT BACKWARDS. THIS DAMAGE IS INDICATIVE OF CLAMP ARM HYPEREXTENSION. WHILE THE EVIDENCE IS INCONCLUSIVE, ENGINEERING CONCLUDED THAT DAMAGE TO THE INSERT ACCESSORY IS MOST LIKELY DUE TO MISHANDLING/MISUSE. ON (B)(6), 2010 (B)(6), (B)(6) HOSPITAL RISK MANAGER STATED THAT DURING A DA VINCI S COLOSTOMY CLOSURE PROCEDURE, A PIECE OF THE HARMONIC CURVED SHEAR (HCS) INSERT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. SHE ALSO STATED THAT A PIECE FROM A REPLACEMENT INSERT ACCESSORY ALSO USED DURING THE SURGICAL PROCEDURE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY. MED WATCH REPORT 2955842-2010-00564 WAS ALSO SUBMITTED REGARDING THIS EVENT.

Description of Event or Problem · 1

ON (B)(4), 2010, ISI RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: END PIECE BROKE OFF AND WAS RETRIEVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONIC CURVED SHEARS INSERT	ENDOSCOPIC ACCESSORY	NAY	INTUITIVE SURGICAL,INC.	400169-07	M10100802

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR			DA VINCI S SURG SYSTEM, HCS INSTRUMENT, ACCSS, ES