MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	TRIEEA25MT
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Human-Device Interface Problem (2949); Noise, Audible (3273); Firing Problem (4011)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during the laparoscopic sigmoid colectomy, when on colonic anastomosis, the green mark was confirm and the lock was release but felt like there was slight resistance.During the firing, there was a hard feel and sound that different from usual.It was noted that only partial firing was performed.At the anastomotic site, only a portion of the anal-side colon/distal colon was resected, and the oral-side colon/proximal colon was not resected at all.The staple was fired, but most of them remained in a u-shape, did not form b-shape and pierced the tissue.From the small abdominal incision, the anvil was manually removed from the stapler, and the anal-side colon/distal colon with a hole was closed with sutures.It was replaced with a new circular stapler, additional resection was performed to the oral-side colon/proximal colon, and the anvil was re-inserted.Re-anastomotic was performed in the anal-side colon/distal colon of the undamaged side.A covering stoma was placed, and the progress was being observed.The surg ical time was extended for 120 minutes as a result.
Additional Manufacturer Narrative
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
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 reporter, during the laparoscopic sigmoid colectomy, when on colonic anastomosis, the green mark was confirm and the lock was release but felt like there was slight resistance.Because the lesion part was low, the anal side became rectal, and the surgical procedure was changed to laparoscopic low anterior resection.During the firing, there was a hard feel and sound that different from usual.It was noted that only partial firing was performed.At the anastomotic site, only a portion of the anal-side colon/distal colon was resected, and the oral-side colon/proximal colon was not resected at all.The staple was fired, but most of them remained in a u-shape, did not form b-shape and pierced the tissue.From the small abdominal incision, the anvil was manually removed from the stapler, and the anal-side colon/distal colon with a hole was closed with sutures.It was replaced with a new circular stapler, additional resection was performed to the oral-side colon/proximal colon, and the anvil was re-inserted.Re-anastomotic was performed in the anal-side colon/distal colon of the undamaged side.A temporary stoma was created, and the progress is being observed.The surgical time was extended for 120 minutes as a result.
Additional Manufacturer Narrative
Additional information: d3 (mfr name and address), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the instrument body label was removed for evaluation of the eccentric washer assembly.The eccentric washer was secured.It was reported that there was staple formation, the staple line was incomplete and had partial cut.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument handle compression is not completed or if the instrument is applied against an excessive amount of tissue during the clinical application.It was also reported that the device was difficult to fire, it has difficulty with safety and the instrument made strange noise.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to squeeze the handle fully during firing may result in unacceptable staple formation and/or an incomplete knife cut.This may result in leakage.Ensure the handle is fully squeezed when the metal underside of the handle contacts the stapler body to the fullest extent.When firing the stapler, make sure to fully squeeze the instrument handle until the metal underside of the handle contacts the stapler body to the fullest extent.Partial or incomplete handle squeezes may result in unacceptable staple formation and/or incomplete knife cut.Staple divots are part of a typical procedure and not considered as a defect.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: EEA
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22367248
• Report Number: 2647580-2025-01994
• Device Sequence Number: 4437452
• Product Code: GAG
• UDI-Device Identifier: 10884521593008
• UDI-Public: (01)10884521593008(17)300131(10)P5B0536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: TRIEEA25MT
• Device Catalogue Number: TRIEEA25MT
• Device Lot Number: P5B0536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 06/15/2025; 08/08/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/09/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown