MAUDE Adverse Event Report: GI WINDOWS SURGICAL FLEXAGON PLUS OTOLOC SYSTEM; MAGNETIC COMPRESSION ANASTOMOSIS SYSTEM

Model Number	100026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is a 73 year male with a history of anemia, stage iv chronic kidney disease, diverticulosis, heart failure, hyperlipidemia, and hypertension, who had a perforated cecum and underwent a right colectomy with ileocolostomy and diverting loop ileostomy in (b)(6) 2025.10 months later the patient was taken for open ileostomy takedown on (b)(6) 2026 with complex parastomal hernia repair.During the open surgical procedure, the patient presented with several issues including evidence of scar tissue, adhesions and a current peristomal hernia.The surgeons made a circular incision around the stoma to free it from the skin and abdominal wall then mobilized the bowel by detaching from the abdomen and pulling it out slightly to locate two healthy, clear ends of the small intestine.The surgeon noted that the distal ileum was very small (less than 12 mm) and required dilation using a hegar dilator starting at 12 mm and continued to 18 mm in order to fit the magnets (25 mm diameter) within each lumen.The magnets operated as expected, despite limited space for the magnet to form in each bowel segment.The magnets were coupled together to complete a full immediate flow anastomosis.After discharge the patient felt unwell and arrived at the hospital for an evaluation.The evaluation assessed the symptoms that could be related to a leak at the anastomosis and surgeons decided that it was necessary to reoperate on (b)(6) 2026.The operation revealed a leak at the anastomosis but both magnets were still coupled together.A new ileostomy was created.The patient had expected healing progression and recovery post procedure and was subsequently discharged from the hospital.

• Brand Name: FLEXAGON PLUS OTOLOC SYSTEM
• Common Device Name: MAGNETIC COMPRESSION ANASTOMOSIS SYSTEM
• Manufacturer (Section D): GI WINDOWS SURGICAL; 480 neponset st.; building 11-b1; canton MA 02021
• Manufacturer (Section G): GI WINDOWS SURGICAL; 480 neponset st.; building 11-b1; canton MA 02021
• Manufacturer Contact: yverre bobay ; 480 neponset st.; building 11-b1; canton, MA 02021
• MDR Report Key: 25572433
• Report Number: 3021969326-2026-00001
• Device Sequence Number: 9064939
• Product Code: SAH
• UDI-Device Identifier: 00860012315536
• UDI-Public: 00860012315536
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K253550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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?: No
• Device Model Number: 100026
• Device Catalogue Number: FFU-CTG-5A
• Device Lot Number: LN205407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 06/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male