MAUDE Adverse Event Report: COVIDIEN LP LIGASURE ADVANCE PISTOL GRIP; LIGASURE VESEL SEALING SYSTEM

Model Number LF5544

Device Problems Break (1069); Defective Component (2292); Material Protrusion/Extrusion (2979)

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

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report : (b)(6) 2015.The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

The customer reported that the handle of the device was defective.There was no injury.The device was returned to covidien for evaluation and initial inspection discovered that the webbing was protruding and the clear insulation was damaged.

Manufacturer Narrative

(b)(4).The knife did not advance when the trigger was activated and it was found that the knife was hitting the back of the blue jaw seal plate.This can happen when the user places excessive tension on the jaws, forcing them out of alignment.The ifu cautions the user to not turn the rotation wheel when the handle is fully closed and latched.Product damage may occur.Do not apply force to the shaft of the instrument causing tension or bowing as this could make the knife difficult to deploy and the trigger may not return to its normal position.When the knife contacted the back of the seal plate, the trigger was forced and this caused the webbing to protrude.The webbing was sharp.The ifu states to gently pull the cutting trigger to engage the cutting mechanism.The clear insulation was damaged.The device failed hipot testing.The ifu states to prevent damage to the flexible insulation proximal to the jaws, confirm the handle is fully closed prior to insertion into and extraction from the cannula.Use the appropriately sized cannula to allow for easy insertion and extraction of the instrument.Failure to do so may impact the integrity of the flexible insulation.Cannulas with hard, non-beveled openings may cause the flexible insulation to retract, which may compromise the insulation.If retraction occurs, the instrument must be discarded.Do not attempt to clean the flexible insulation.Cleaning may damage insulation.

• Brand Name: LIGASURE ADVANCE PISTOL GRIP
• Type of Device: LIGASURE VESEL 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: 5270355
• MDR Text Key: 33010522
• Report Number: 1717344-2015-00876
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 51470168X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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