MAUDE Adverse Event Report: Covidien Surgical Signia; STAPLE, IMPLANTABLE

Model Number	SIGCIRSTND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abdominal Pain (1685); Abscess (1690); Atrial Fibrillation (1729); Fever (1858); Tachycardia (2095); Vomiting (2144); Bowel Perforation (2668); Syncope/Fainting (4411)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to a clinical study, on (b)(6)2026, a week following a robotic low anterior resection for a rectal mass involving a powered surgical handle, circular adapter, power shell, and circular reload, the patient presented with abdominal pain, syncope, vomiting, fever, and tachycardia.The patient was found to have an atrial fibrillation with rapid ventricular response, anastomotic leak of the intestine, bowel perforation, and intra-abdominal abscess requiring emergent diagnostic laparoscopy, abscess drainage, laparoscopic partial colectomy, and permanent end colostomy.The event resulted in new inpatient hospitalization from 03-aug-2026 through 13-aug-2026.The investigator assessed the event as possibly related to the study procedure and study device.The sponsor assessed a causal relationship to the study procedure and a possible relationship to the study device.
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle, (serial # c23aah0329) sigpshell, sig power sigpshell control shell, (lot # n6d1109y) sigcir28mt, ts 2.0 sigcir28mt circ.28mm med/thick, (lot # n5k1404uy) 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.

• Brand Name: Signia
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50386530
• Report Number: 1219930-2026-05342
• Device Sequence Number: 15749714
• Product Code: GDW
• UDI-Device Identifier: 10884521845480
• UDI-Public: (01)10884521845480(11)241118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: SIGCIRSTND
• Device Catalogue Number: SIGCIRSTND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2026
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Other; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 225 LB