MAUDE Adverse Event Report: SURGICAL ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030458
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Stenosis (2263); Unintended Radiation Exposure (4565)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: 030459 endo gia r/or 60 4.8mm (lot#: unknown) 030458 endo gia r/or 60 3.5mm (lot#: unknown) 030459 endo gia r/or 60 4.8mm (lot#: unknown) elghadban, h., shoma, a., abdallah, e., negm, a., abdullah, e., hamed, h., ghareeb, s., lotfy, a., and taki-eldin, a.Laparoscopic one anastomosis gastric bypass as a revisional procedure after failed vertical banded gastroplasty: our center experience.Journal of obesity, volume 2025, article id 4161005, https://doi.Org/10.1155/jobe/4161005; pages 1-8 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the literature, a retrospective study evaluated the safety, efficacy, and outcomes of one anastomosis gastric bypass (oagb) as a revisional procedure following failed vertical banded gastroplasty (vbg).Seventy-one patients underwent the procedure between february 2014 and february 2020.A stapler cartridge (60mm, blue) was used to perform the anastomosis between the gastric pouch and small bowel.The stapling defect was closed with a competitor suture.Postoperative complications included one case (1.4%) of anastomotic stricture, which was managed by upper gi endoscopy and balloon dilatation, indicating a serious injury event.Other complications included bleeding requiring transfusion, leakage managed by endoscopy or stent, and an abscess managed by drainage and antibiotics.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22475611
• Report Number: 1219930-2025-02929
• Device Sequence Number: 8555161
• Product Code: GDW
• UDI-Device Identifier: 10884523002898
• UDI-Public: 10884523002898
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 030458
• Device Catalogue Number: 030458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/10/2025
• 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 NOTE ON H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female