FDA Adverse Event Malfunction Summary report: N

LIGASURE IMPACT

MDR report key: 3190811 · Received June 14, 2013

Report

Report Number: 3006451981-2013-00188
Event Type: Malfunction
Date Received: June 14, 2013
Report Date: May 28, 2013
Manufacturer: COVIDIEN LLC (SHANGHAI)
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A VISUAL INSPECTION SHOWED TISSUE IN-BETWEEN THE JAWS AND THE JAWS WERE STUCK SHUT. THE KNIFE WAS PROTRUDING FROM THE JAWS AND THE JAWS HAD TO BE PRIED OPEN. THE KNIFE WEBBING WAS BENT. THIS FAILURE MODE HAS BEEN DUPLICATED IN ENGINEERING EVALS BY CLAMPING ON LARGE, RIGID TISSUE. A DEVICE HISTORY REVIEW HAS BEEN COMPLETED. NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED. THE IFU FOR THIS DEVICE WARNS AGAINST OVERFILLING THE INSTRUMENT JAWS SO AS NOT TO COMPROMISE THE CUTTING FUNCTION. THE IFU STATES TO CONFIRM THE JAWS HAVE REACHED THE CLOSED POSITION BEFORE ACTIVATING THE CUTTER OR THE CUTTER MAY NOT SECURELY STAY WITHIN THE GUIDING TRACK OF THE JAWS. THE IFU STATES TO ELIMINATE TENSION ON THE TISSUE WHILE SEALING AND CUTTING TO ENSURE PROPER FUNCTION. COVIDIEN LP IMPLEMENTED A JAW/BLADE DESIGN TO INCREASE THE BLADE RETENTION WITHIN THE JAWS OF THE HANDPIECE. THIS MAKES THE DESIGN MORE ROBUST TO VARIATIONS IN USER TECHNIQUE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT DURING A VAGINAL HYSTERECTOMY, THE DEVICE KNIFE CAME OUT OF THE TRACK AND WAS TRAPPED WITHIN THE JAWS. THERE WAS NO PT INJURY. WHEN THE DEVICE WAS RETURNED TO COVIDIEN FOR EVAL, IT WAS FOUND THAT THE KNIFE BLADE WAS EXPOSED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
272284	LIGASURE IMPACT	LIGASURE VESSEL SEALING SYSTEM	GEI	COVIDIEN LLC (SHANGHAI)		S3AF030PX

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK