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

Model Number LF4200

Device Problems Retraction Problem (1536); Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

The customer originally reported that the knife blade did not retract.When the device was received for investigation on (b)(4) 2015, it was noted that the knife blade was protruding from the jaws.

Manufacturer Narrative

(b)(4).The incident device was returned and a visual inspection revealed that the knife was protruding from the jaws of the device.Knife trap happens when the blade is extended and the jaws are not completely closed.The investigation identified the root cause of the reported event to be knife trap due to user error.The ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.

• Brand Name: LIGASURE IMPACT
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301
• MDR Report Key: 4684116
• MDR Text Key: 19306775
• Report Number: 1717344-2015-00268
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF4200
• Device Catalogue Number: LF4200
• Device Lot Number: 238524LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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