MAUDE Adverse Event Report: COVIDIEN LP LIGASURE IMPACT LF4318; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LF4318

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One device was received for evaluation.Visual inspection found the knife was protruding from the jaws.The sample gave a regrasp alarm due the knife trapped and protruding from the jaws.Knife trap happens when the blade is extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.Per the ifu, the jaws should be closed and locked before activating the cutter.A device history review was completed and no entries pertinent to the customer's report were noted.

Event Description

The customer reported that the device did not activate on first seal attempt.There was no injury to the patient.The device was returned to covidien for inspection and initial evaluation discovered that the knife blade is protruding from the jaws.

• Brand Name: LIGASURE IMPACT LF4318
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5004277
• MDR Text Key: 24244400
• Report Number: 1717344-2015-00564
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: LF4318
• Device Lot Number: 50290234X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1