FDA Adverse Event Malfunction Summary report: N

LIGASURE ATLAS HANDSWITCHING 37CM

MDR report key: 998394 · Received February 8, 2008

Report

Report Number: 1219930-2008-00065
Event Type: Malfunction
Date Received: February 8, 2008
Date of Event: January 9, 2008
Report Date: January 9, 2008
Manufacturer: COVIDIEN LP (VALLEYLAB)
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

WHILE THE EVALUATION OF THE INCIDENT DEVICE SHOWED THE DEVICE PERFORMS ACCORDING TO SPECIFICATION, TURNING THE ROTATION WHEEL WHILE THE HANDLE IS FULLY CLOSED CAN CAUSE THE JAWS TO LOCK SHUT. THERE IS A NOTICE IN THE INSTRUCTIONS FOR USE (IFU) THAT STATES, "DO NOT TURN THE ROTATION WHEEL WHEN THE HANDLE IS LATCHED. PRODUCT DAMAGE MAY OCCUR. THE JAWS MAY LOCK IN THE CLOSED POSITION." ADDITIONALLY, COVIDIEN LP (FORMERLY VALLEYLAB) HAS ALSO FOUND THAT IF THE JAWS ARE NOT CLEANED AS INSTRUCTED IN THE IFU, ESCHAR CAN BUILDUP AND CAUSE THE JAWS TO STICK TO THE SEALED TISSUE. COVIDIEN LP (FORMERLY VALLEYLAB) HAS ISSUED A HOTLINE BULLETIN TO INFORM CUSTOMERS ON HOW TO AVOID TISSUE BUILDUP THAT CAN LEAD TO STICKING. COVIDIEN'S VP OF MEDICAL AFFAIRS IS IN CONTACT WITH THE SITE TO OBTAIN FURTHER INFORMATION ON THIS INCIDENT. IF FURTHER INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE ISSUED.

Description of Event or Problem · 1

THE REPORT STATED THAT DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY THE JAWS OF THE LIGASURE ATLAS LOCKED CLOSED ON THE PATIENT'S TISSUES. THE SURGEON USED ANOTHER INSTRUMENT TO RESECT AROUND THE HANDPIECE AND REMOVE IT. THERE WAS SLIGHT ADDITIONAL TISSUE AND BLOOD LOSS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIGASURE ATLAS HANDSWITCHING 37CM	LIGASURE VESSEL SEALING SYSTEM	GEI	COVIDIEN LP (VALLEYLAB)		U7K113

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK