MAUDE Adverse Event Report: COVIDIEN LP LIGASURE PRECISE+; LIGASURE VESSEL SEALING SYSTEM

Model Number LF1212

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer that during a procedure, the insulating material on the tip was found partially broken.The broken piece was missing and could not be located.The piece might have fallen into the patient's cavity.Another device was used to continue the procedure.No patient injury reported.

Manufacturer Narrative

(b)(4).Date of follow-up report : 11/03/2015.One used lf1212 was received for evaluation.Visual inspection found the jaw melted at the tip.The customer reported the insulating material on the tip was found partially broken.The investigation found the tip of one of the electrode jaws was charred and melted.No piece appeared to be broken off but had melted and exposed a portion of the metal on the tip of the jaw.The tip may have contacted a metal instrument causing an increase in current flow.This is an isolated incident, no other complaints of this nature have been reported.The investigation identified the root cause of the reported event to be attributed to user technique or contacting a metal instrument.The instructions for use cautions the user to not use the lf1212 as a bipolar scissors.Continual activation to separate tissue promotes eschar buildup on seal surfaces that can reduce the effectiveness of the seal and may create a condition that compromises the jaws insulating coating.The ifu warns, contact between an active instrument electrode and any metal object (hemostats, staples, clips, retractors, etc.) may increase current flow and may result in unintended surgical effects.No trend has been identified for this failure mode.

• Brand Name: LIGASURE PRECISE+
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301
• MDR Report Key: 5137142
• MDR Text Key: 27818241
• Report Number: 1717344-2015-00699
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LF1212
• Device Catalogue Number: LF1212
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• 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): Other