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

Model Number	030452
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a revision of bariatric surgery from sleeve gastrectomy to roux-en-y gastric bypass procedure, total of 5 cartridges were fired to divide the stomach and gastro-jejunal (g-j) anastomoses.The procedure and everything went well and there was no unusual event with instrument or while stapling.However, at the end of the procedure when doctor performed a methylene blue test, the staple line at g-j anastomoses leaked and methylene blue came out from staple line.The doctor over sewed the staple line which leaked.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the loading unit was fully fired.Functionally the loading unit was loaded into a pmv representative instrument and was cycled without hesitation or binding.In addition (pmv) performed a photographic evaluation of one image and the visual inspection of the returned photo noted that the malformed staples were on tissue.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8701207
• Report Number: 1219930-2019-03478
• Device Sequence Number: 19407930
• Product Code: GDW
• UDI-Device Identifier: 10884523002836
• UDI-Public: 10884523002836
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 030452
• Device Catalogue Number: 030452
• Device Lot Number: N8E0711KRX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 10/19/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention