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

Catalog Number LF4200

Device Problems Failure to Cut (2587); Material Protrusion/Extrusion (2979)

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

Event Date 05/05/2015

Event Type  malfunction  

Event Description

The customer reported that the device failed to cut during the procedure.It was not used on the patient.The device was returned for evaluation and initial inspection discovered that the knife blade was protruding from the jaws.

Manufacturer Narrative

(b)(4).One device was received for evaluation.Visual inspection found the knife was protruding from the jaws.The jaws would not open or close due to the protruding knife.The customer's reported condition was confirmed and attributed to user error.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.The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have reduced the difficulty in activating the knife.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.

• Brand Name: LIGASURE IMPACT
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder
• Manufacturer Contact: sharon murphy ; 5290 longbow dr.; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4835123
• MDR Text Key: 5945576
• Report Number: 1717344-2015-00414
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: LF4200
• Device Lot Number: 240346LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1