FDA Adverse Event Malfunction Summary report: N

NEW LIGASURE 5MM

MDR report key: 1841443 · Received September 15, 2010

Report

Report Number: 1717344-2010-00648
Event Type: Malfunction
Date Received: September 15, 2010
Date of Event: August 18, 2010
Report Date: August 19, 2010
Manufacturer: COVIDIEN LP, (VALLEYLAB)
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COVIDIEN REFERENCE #: (B)(6). DATE OF INITIAL REPORT: (B)(6)2010. THE HANDLE OF THE INCIDENT DEVICE WAS LATCHED CLOSED AS RECEIVED. THE JAWS WERE STUCK TOGETHER DUE TO EXCESSIVE DRIED TISSUE. WHEN THE JAWS WERE CLEANED OF TISSUE, THE JAWS OPENED NORMALLY. TESTING CONFIRMED THAT THE KNIFE TRIGGER WOULD FREQUENTLY REMAIN IN THE FULLY ACTUATED POSITION UNTIL THE LATCH HANDLE WAS RELEASED. ONCE THE LATCHING HANDLE IS RELEASED, THE JAWS WILL OPEN NORMALLY. THE IFU FOR THIS DEVICE STATES TO OPEN THE JAWS BY PUSHING FORWARD ON THE HANDLE. IN ADDITION, COVIDIEN LP (FORMERLY VALLEYLAB) PROVIDES AN ONLINE BULLETIN TO INFORM CUSTOMERS HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING. THIS BULLETIN REITERATES INFO PROVIDED IN THE IFU WHICH STATES THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED, ESCHAR CAN BUILD UP AND CAUSE THE JAWS TO STICK TO THE SEALED TISSUE. THIS CAN LEAD TO DIFFICULTY IN OPENING AND CLOSING THE DEVICE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE INSTRUMENT JAWS CLOSED AND WOULD NOT OPEN WHEN ON A VESSEL DURING A GYN CASE. THE DR CONTINUED TO ACTIVATE THE DEVICE AND THEN USED ANOTHER INSTRUMENT TO PRY OPEN THE JAWS. THERE WAS NO INJURY TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEW LIGASURE 5MM	LIGASURE VESSEL SEALING SYSTEM	GEI	COVIDIEN LP, (VALLEYLAB)		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK