FDA Adverse Event Malfunction Summary report: N

LIGASURE PRECISE

MDR report key: 1062801 · Received June 17, 2008

Report

Report Number: 1717344-2008-00277
Event Type: Malfunction
Date Received: June 17, 2008
Date of Event: May 20, 2008
Report Date: May 21, 2008
Manufacturer: COVIDIEN LP (VALLEYLAB)
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SITE HAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED. FURTHER INFO HAS BEEN REQUESTED. COVIDIEN LP (FORMERLY VALLEYLAB) HAS INVESTIGATED REPORTS OF THE BLUE INSULATION MELTING ON THE PRECISE LS1200. ANALYSIS OF RETURNED PRODUCTS SHOWS THAT ALTHOUGH THERE CAN BE SOME DEGRADATION OF THE COATING, IN MOST CASES THIS DOES NOT HAVE A NEGATIVE CLINICAL OR SAFETY OUTCOME. THE INSTRUCTIONS FOR USE HAVE BEEN MODIFIED TO ADD A CAUTION INDICATING THAT THE LS1200 SHOULD NOT BE USED AS BIPOLAR SCISSORS. THE INSTRUCTIONS FOR USE ALSO CONTAINS A WARNING TO AVOID INADVERTENT CONTACT WITH THE PT, AS A BURN MAY RESULT. ALTHOUGH THE REPORTED INJURY RATE FOR THIS ISSUE IS VERY LOW, A PROJECT IS UNDERWAY TO INVESTIGATE A MORE ROBUST COATING MATERIAL. REPORTED INJURIES HAVE BEEN MINOR IN NATURE WITHOUT SERIOUS EFFECT TO THE PT. IF PERTINENT INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE REPORT STATED THAT BLUE PIECES FELL OFF THE DEVICE. SOME FELL INSIDE THE PT AND WERE REMOVED BY THE NURSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIGASURE PRECISE	LIGASURE VESSEL SEALING SYSTEM	GEI	COVIDIEN LP (VALLEYLAB)		137444

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK