MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIA60AMT

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Failure to Form Staple (2579)

Patient Problems Fever (1858); Blood Loss (2597); No Code Available (3191)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, 14 days after robotic and laparoscopic lobectomy, the patient entered the hospital again with fever and blood sputum.Bronchoscopy was done and it was found out that the staple line was incomplete, there was a poor staple formation and there were loose staples in the respiratory airway.The patient also had a blood loss of 500cc or more.After a month of being hospitalized, the bronchus naturally closed and also used an antibiotic.Re-hospitalization and clinical treatment were done to resolve the problem.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one photograph and three videos.A visual inspection of the returned photos noted no staple lines were observed.No visual abnormalities could be observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.Without the physical product, a definitive root cause could not be identified.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: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8742235
• MDR Text Key: 149470659
• Report Number: 1219930-2019-03779
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 30884523003219
• UDI-Public: 30884523003219
• Combination Product (y/n): N
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: N8M0351KY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 58