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

Catalog Number LF5544

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report : 11/06/2015.The knife did not extend or retract when the trigger was activated.The knife is contacting the back of the seal plate.This can happen when excessive tension is placed on the jaws, forcing them out of alignment.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 but all pieces were still attached.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.

Event Description

The customer reported that the device stopped cutting during a diagnostic laparoscopic procedure.A new device was used to complete the case and there was no injury to the patient.The device was returned to covidien and initial inspection discovered that the webbing was protruding and the insulation was damaged.

• Brand Name: LIGASURE ADVANCE PISTOL GRIP
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5208750
• MDR Text Key: 30887128
• Report Number: 1717344-2015-00791
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF5544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• 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
• Patient Outcome(s): Disability