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

Model Number UNKNOWN GENERATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Stenosis (2263); Ulcer (2274); Melena (4480); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/08/2018

Event Type  Injury  

Manufacturer Narrative

Title: efficacy of utilizing argon plasma coagulation for weight regain in roux-en-y gastric bypass patients: a multi-center study source: obesity surgery (2018) 28:2737¿2744 https://doi.Org/10.1007/s11695-018-3229-5 published online: 8 april 2018 springer science+business media, llc, part of springer nature 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source study performed last 31st july 2009 and 29th march 2017.Moon et al.5 described a retrospective case series across 558 patients at eight bariatric centers (1 in the us, 7 in brazil) to treat patients for weight regain after bariatric surgery, during which the wem apc generator was used along with erbe generator and erbe usa argon plasma coagulator (apc¿) circumferential probe.In this study, endoscopic argon plasma coagulator (apc) was utilized in the attempt to decrease the diameterof dilated gastrojejunostomy and therefore reinitiate weight loss in roux-en-y gastric bypass (rygb) patients.Only four centers provided data for complication (n=333 patients).A total of 18 (5.4%) patients experienced complication after argon plasma coagulator (apc), including stenosis (n = 9), gj ulcer (n = 3), gj leakage (n = 2), and melena (n = 1).

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.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: UNKNOWN GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 11629119
• MDR Text Key: 244255461
• Report Number: 1717344-2021-00529
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN GENERATOR
• Device Catalogue Number: UNKNOWN GENERATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR