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

Model Number LF5544

Device Problems Material Protrusion/Extrusion (2979); Mechanical Jam (2983)

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

Event Date 05/11/2015

Event Type  malfunction  

Event Description

The customer reported that the device jaws jammed.The surgeon was unable to open and close them.Upon return for investigation the knife was protruding from the jaws and the clear insulation was damaged and failed hipot.

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.

Manufacturer Narrative

(b)(4).Date of follow-up report : (b)(6) 2015.One used lf5544 was received for evaluation.The returned sample did not meet specification as received.A review of the lot number reported in cts indicates that the product was within the assigned expiration date at the time of reported incident.Visual inspection found knife protruding from the jaws and the clear insulation is damaged.The reported condition was confirmed.The knife is 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 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.An additional failure was found during the investigation; the clear insulation is damaged.The additional findings did not contribute to the reported condition; however, the sample failed hi-pot 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.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.

• Brand Name: LIGASURE ADVANCE PISTOL GRIP
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow dr.; boulder, CO ; 2034925267
• MDR Report Key: 4914027
• MDR Text Key: 6012012
• Report Number: 1717344-2015-00462
• 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 Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 43460086X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• 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