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

Model Number LF5544

Device Problems Material Protrusion/Extrusion (2979); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report : 10/27/2015.One used lf5544 was received for evaluation.Visual inspection found knife web protruding from the clevis area.The web is not sharp.The web protruding caused a small hole in the clear insulation.The reported condition of the knife not advancing was confirmed.The jaws opened and closed normally when the handle was activated.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 force was continued to be exerted on the trigger.The force caused the knife web to break and protrude from the clevis area.The investigation identified the root cause of the reported event to be user error.The ifu cautions: do 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.

Event Description

The customer reported that during a colon resection that the knife would not advance to cut the tissue that was sealed by the device.The device was returned for evaluation with the knife web (non-sharp) protruding from the clevis area and the device failed hi-pot testing due to the clear insulation being torn.

• 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: 5181907
• MDR Text Key: 30048342
• Report Number: 1717344-2015-00720
• 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: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 51960111X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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