MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLER, SURGICAL

Model Number	EEAXL2835
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
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 a laparoscopic sigmoid colectomy procedure for the treatment of ischemic heart disease, after firing for the rectal anastomosis, the anvil head fell over or collapsed.When extracting the handle, it got caught strongly, and when the intestinal tract was checked after removal, it has torn vertically by about five centimeters (cm).Starting one cm on the oral side of the anastomosis and extending approximately four cm beyond the anastomosis on the anal side.It was completely torn inside the abdominal cavity to the extent that the rectal cavity was visible.The donut ring has been confirmed without any issues, with the entire circumference and all layers checked on both the oral and anal sides.The anal side was detached/moved from the laceration part, and additional resection of seven cm of the rectum and anastomosis were performed.This resulted in surgical time extension by three to four hours.To complete the case, a new stapler was used.A stoma was not placed, and the postoperative progress was monitored.
Additional Manufacturer Narrative
Correction: h6 (ime, fdd added) 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 conducted an investigation based upon all information received.The device and a photo were available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the anvil disengaged and the device was difficult to remove from cavity.The reported issues were not confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21201348
• Report Number: 2647580-2025-00265
• Device Sequence Number: 12847463
• Product Code: GAG
• UDI-Device Identifier: 10884523006148
• UDI-Public: 10884523006148
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Device Lot Number: P3D0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 03/21/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/05/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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
• Patient Sex: Unknown