MAUDE Adverse Event Report: COVIDIEN SURGICAL TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIGCIR28MT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hernia (2240); Swelling/ Edema (4577)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, following a colostomy takedown procedure on (b)(6) 2026, a serious post-procedure perioperative dehiscence of the abdominal wound with evisceration occurred.The patient was presented to an emergency department after noticing ¿something poking out¿ while changing the dressing.A computed tomography scan of the abdomen and pelvis with intravenous contrast showed a new spigelian hernia containing a small bowel segment, with the small bowel contacting and projecting slightly beyond the skin surface, along with mural edema and pneumatosis that raised concern for bowel ischemia, and there was also concern for a suspected abscess that was not drainable.The event required a new hospitalization on (b)(6) 2026 and surgical treatment for evisceration of the colostomy closure site with a loop of small bowel eviscerated; all bowel was reported viable, and fascial closure with vicryl mesh underlay was performed.Medication changes were made due to the adverse event.The sponsor assessed the event as possibly related to the study procedure and possibly related to the study device.The outcome was reported as recovering/resolving.
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle (serial # (b)(6)); sigpshell, sig power sigpshell control shell (lot # n5e1708y); sigcirstnd, sigcirstnd signia circ adapt std length (serial # (b)(6) ).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.
Additional Manufacturer Narrative
Additional information: b2, b5, g3 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
It was reported that, following a colostomy takedown procedure on april 14, 2026, a serious post-procedure perioperative dehiscence of the abdominal wound with evisceration occurred.The patient was presented to an emergency department after noticing ¿something poking out¿ while changing the dressing.A computed tomography scan of the abdomen and pelvis with intravenous contrast showed a new spigelian hernia containing a small bowel segment, with the small bowel contacting and projecting slightly beyond the skin surface, along with mural edema and pneumatosis that raised concern for bowel ischemia, and there was also concern for a suspected abscess that was not drainable.The event required a new hospitalization on (b)(6) 2026 and ended on (b)(6) 2026.Surgical treatment for evisceration of the colostomy closure site with a loop of small bowel eviscerated; all bowel was reported viable, and fascial closure with vicryl mesh underlay was performed.Medication changes were made due to the adverse event.The event led to serious deterioration in the health of the patient.The sponsor assessed the event as possibly related to the study procedure and possibly related to the study device.The investigator assessed the event as having causal relationship to the study procedure and not related to the study device.The outcome was reported as recovering/resolving.

• Brand Name: TRI-STAPLE 2.0
• 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 55112-4391 ; 8006464633
• MDR Report Key: 25101460
• Report Number: 1219930-2026-03047
• Device Sequence Number: 5079119
• Product Code: GDW
• UDI-Device Identifier: 10884521703728
• UDI-Public: (01)10884521703728(17)280831(10)N5J1407UY
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: SIGCIR28MT
• Device Catalogue Number: SIGCIR28MT
• Device Lot Number: N5J1407UY
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 09/09/2025
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White