MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE EXACT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number LF2019

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during subtotal glossectomy, marginal mandibulectomy, tracheostomy, the tip of the device broke off and fell to patients cavity and did not retrieved.The procedure was completed with another device.The investigation communication stated that the patient was undergone x-ray.

Manufacturer Narrative

One devices was received for evaluation.The returned product did not meet specification as received because of the broken tip of the jaw.Visual inspection found that the plastic tip on the jaws fractured.The broken pieces were not returned.The reported condition was not confirmed, because it could not be determined at what process step the tip fracture occurred.The rfid logs taken from the device indicate the product was used on a generator.The insulation tip was broken by damage from an external force, consistent with the user inadvertently grasping onto a hard object, where led to the chipping of the insulation.Manufacturing and supplier were ruled out as the possible cause of the fracture by the engineering.The device was plugged into a generator and was recognized.The device was activated ten times on a saline soaked towel with satisfactory results.The investigation identified the root cause of the reported event to be user.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE EXACT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8723528
• MDR Text Key: 148814202
• Report Number: 1717344-2019-00796
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521741096
• UDI-Public: 10884521741096
• Combination Product (y/n): N
• PMA/PMN Number: K173281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: 90300120X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR