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

Model Number LF5544

Device Problems Break (1069); Failure to Cut (2587); Material Protrusion/Extrusion (2979)

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

Event Date 06/05/2014

Event Type  malfunction  

Event Description

The customer reported that the surgeon couldn't pull the cutting trigger, so the surgeon couldn't cut the tissue.Upon receipt for investigation the device had one of the webs protruding from the clevis area, the webbing was not sharp.Additionally, the clear insulations is also damaged and the device failed hipot testing.

Manufacturer Narrative

(b)(4).One used lf5544 was received for evaluation and visual inspection found one of the knife webs was protruding from the clevis area.The web was not sharp.The clear insulation was also damaged.The customer reported that the surgeon couldn't pull the cutting trigger, so the surgeon couldn't cut the tissue.The reported condition was confirmed.The investigation found 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, the trigger was forced and this caused one of the webs to break and protrude from the sample.The investigation identified the root cause of the reported event to be user error.The ifu states: 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.The ifu states to gently pull the cutting trigger to engage the cutting mechanism.An additional failure was found during the investigation, the clear insulation was damaged.The sample failed hi-pot testing.The investigation identified the root cause of the reported event to be user error.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.

• 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: 4354129
• MDR Text Key: 5144887
• Report Number: 1717344-2014-01087
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 252805X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2013
• 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