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

Model Number LF4200

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.Further contact information for the initial reporter has been requested.

Event Description

The customer reported that the blade of the device was stuck within initial use.Examination of the received device on december 23rd found a different model had been returned than originally reported.The customer confirmed that the originally reported model was incorrect.Examination of the received sample also found the knife was trapped and protruding from the jaws.

Manufacturer Narrative

Medtronic reference #: (b)(4).Date of initial report: 01/21/2017.Date of follow-up report: 02/20/2017.On lf4200 was received for evaluation.Visual inspection found the knife trapped and protruding from the jaws.The knife was 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.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 also reduced the difficulty activating the knife.The device was activated on a simulated tissue with acceptable results and a visual seal effect was observed.The investigation identified the root cause of the reported event to be 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.Do not overfill the jaws of the instrument with tissue.This may damage the cutting mechanism or cause the blade to deploy outside of its guiding feature, possibly resulting in difficulty opening the jaws or unintended injury to the user or patient.No trend has been identified.No corrective action is required, because no trend has been identified.Manufacturing non-conformances were reviewed.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 CO 80301
• Manufacturer (Section G): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6269023
• MDR Text Key: 65461365
• Report Number: 1717344-2017-00068
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010013
• 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,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: LF4200
• Device Catalogue Number: LF4200
• Device Lot Number: 256248LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1