MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030419
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Rupture (2208); Tissue Breakdown (2681)
Date of Event	01/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant product: egia45avm egia 45 artic vasc med sulu (lot#: unknown) 030451 roticultr endo gia 30-2.5 dlu (lot#: t3f049x) egiaustnd endogia ultra univ std stap (lot#: unknown).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, the patient underwent surgery on call for a laparoscopic appendectomy.Three staple magazines were used during the operation, at the moment it was not possible to report which magazine crashed into the manual handle.According to the operating room nurse and the surgeon, they found nothing abnormal at the staple line or any foreign material in the abdomen.9 days after the laparoscopic appendectomy surgery, reoperation was done where the staple line has ruptured.Correction of stapling line by sutures was made, drainage of abscess and search for foreign body was done to resolve the issue.It was also noted that fecalitis was found, which involves the distal ileum and the cecal pole.No foreign material can be found in the abdomen.
Event or Problem Description
According to the reporter, the patient underwent surgery on call for a laparoscopic appendectomy.Three staple magazines were used during the operation, at the moment it was not possible to report which magazine crashed into the manual handle.According to the operating room nurse and the surgeon, they found nothing abnormal at the staple line or any foreign material in the abdomen.9 days after the laparoscopic appendectomy surgery, reoperation was done where the staple line has ruptured.There was staple line leak.Correction of stapling line by sutures was made, drainage of abscess and search for foreign body was done to resolve the issue.It was also noted that fecalitis was found, which involves the distal ileum and the cecal pole.No foreign material can be found in the abdomen.
Additional Manufacturer Narrative
Additional information: g3 correction: b5, h6.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: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 21398187
• Report Number: 2647580-2025-00538
• Device Sequence Number: 9199604
• Product Code: GDW
• UDI-Device Identifier: 10884523002966
• UDI-Public: 10884523002966
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K111825
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 030419
• Device Catalogue Number: 030419
• Device Lot Number: P2D0092
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/27/2025
• Date Device Manufactured: 04/06/2022
• 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