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

Model Number	EGIATRS60AXT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Dehydration (1807); Diarrhea (1811); Purulent Discharge (1812); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Emotional Changes (1831); Erythema (1840); Fever (1858); Heartburn/Indigestion (1883); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Perforation (2001); Vomiting (2144); Chills (2191); Discomfort (2330); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Swollen Lymph Nodes/Glands (4432); Nodule (4551); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.It was reported that the patient experienced a life threatening serious injury that resulted from use of the device.Treatment included intensive care treatment, extended hospitalization, and subsequent surgeries to correct the injuries.
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.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The patient underwent a laparoscopic sleeve gastrectomy.Post operatively, the patient began to experience lack of eating, dehiscence, fluid collection, gastric leak, congestion, perforation, abscess, abdominal pain, nausea, vomiting.Treatment included intensive care treatment, extended hospitalization, ct scans, drainage placements, feeding tubes, pigtail drain, subsequent surgeries to correct the injuries.
Additional Manufacturer Narrative
Correction: e1, e3, g3, g6, h2 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.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The patient underwent a laparoscopic sleeve gastrectomy.Post operatively, the patient began to experience abnormal blood work, hiatal hernia, phlegmonous changes, adenopathy, tract from abscess to skin, altered mental status, diarrhea, dehydration, fever, pain, distention, tenderness, purulent fluid, perforation, heart burn, redness, myalgia, tender mass, chills, shortness of breath, bloody drainage, fibrinous reaction, dysphagia, lack of eating, dehiscence, fluid collection, gastric leak, congestion, perforation, abscess, abdominal pain, nausea, vomiting.Treatment included iv fluids, pain medications, antibiotics, nausea medication, picc line for tpn, intensive care treatment, extended hospitalization, ct scans, drainage placements, feeding tubes, pigtail drain, subsequent surgeries to correct the injuries.
Additional Manufacturer Narrative
Additional info: a1, a2, a4, a5a, a5b, b5, b6, b7, d1, d4 (model #, lot #, udi), d8, g1, g4 (pma / 510(k)), h5, h6 (patient codes, health impact codes, e2404: abnormal blood work, tract) 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
Additional info: d6a, d10 (unknown stapler; sigtrs60amt; 60mm endo-gia tri-staple purple reloads (1); 45mm endo-gia black reloads (2); 60mm endo-gia black reloads (2); and 60mm tri-staple signia (1)).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
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 13418834
• Report Number: 1219930-2022-00389
• Device Sequence Number: 11979456
• Product Code: GDW
• UDI-Device Identifier: 10884521191006
• UDI-Public: 10884521191006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/25/2023

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 Model Number: EGIATRS60AXT
• Device Catalogue Number: EGIATRS60AXT
• Device Lot Number: N9C1218Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 07/06/2022; 07/28/2023; 10/05/2023
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/28/2022; 07/06/2022; 08/29/2023; 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White