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

Model Number	LF1723
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during video-assisted thoracoscopic surgery, partial lung resection, the knife came out from the jaws and could not be returned in the middle of the procedure, because the device was not able to be used, another new device was opened to complete the procedure.When the device was checked, although the knife was already stored, because there were many stains on the jaws, there was a possibility that the knife return was hindered by the attachment of eschar due to insufficient cleaning.There was no patient injury.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Initial visual inspection found no defects.The reported condition was confirmed.The manufacturing engineer was notified and confirmed that product did not meet s pecifications.The knife blade shall self-return when the trigger is actuated.Examination of the discrepant device revealed that the red wire was contacting the blade extend/retract hook and appeared to catch in the hook/outer tube guide slot.When the blade was activated, the jaw wire caused friction in the blade actuation mechanism.Consequently, the red wire stopped the blade from retracting properly.This caused the non-retracted blade that the customer reported.The most probable cause for this defect is the wire was not pulled tight in the wire fixture and the slack loop caught on the blade extend/retract hook.This is a manufacturing related defect.The investigation identified the root cause of the reported event to be a manufacturing error.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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8217621
• Report Number: 1717344-2019-00024
• Device Sequence Number: 1710539
• Product Code: GEI
• UDI-Device Identifier: 10884521181588
• UDI-Public: 10884521181588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: LF1723
• Device Catalogue Number: LF1723
• Device Lot Number: 82130344V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 03/18/2019; 04/30/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 04/05/2019; 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1