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

Model Number	GIA6038S
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Emotional Changes (1831); Inflammation (1932); Pain (1994); Shock (2072); Ascites (2596); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/16/2021
Type of Reportable Event	Death
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
Correction: d4 (unique identifier (udi) #), e1, g1.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
The product was used for a small bowel resection with anastomosis.During subsequent surgery it was discovered that the free end of the small bowel staple line had leakage along the staple line indicative of a failed staple line and the anastomosis did not seal.It was reported that after use, the patient experienced surgical stapler failure, failure to the stapler device, bowel leakage, defective device, pain, shock, mental anguish, unable to perform normal activities, leukocytosis, ascites, serositis, and death.Post-operative patient treatment included exploratory laparotomy with lysis of adhesions, small bowel resection with primary anastomosis, diverting loop ileostomy, & ct scan.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration.
Additional Manufacturer Narrative
H6 ime e2402: leukocytosis.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 info: b5, g1, h6 (removed and added patient codes, device codes), changed additional codes.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 an open small bowel anastomosis, the surgeons were repairing the failed anastomosis and the first firing was satisfactory to the surgeons but the second firing had a hole and did not seal.A temporary staple line was created using an ultra universal stapler for the intralumenal anastomosis and then closed the anastomosis with a linear stapler and thus this staple line was cut off as a normal part of closing the common opening with the linear stapler.It was noted that there was tissue damage.

• Brand Name: GIA
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 21425379
• Report Number: 2647580-2025-00580
• Device Sequence Number: 18139383
• Product Code: GAG
• UDI-Device Identifier: 10884523007237
• UDI-Public: (01)10884523007237(17)260531(10)P1F1504
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 05/31/2026
• Device Model Number: GIA6038S
• Device Catalogue Number: GIA6038S
• Device Lot Number: P1F1504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/02/2025; 08/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/30/2025; 08/11/2025
• Date Device Manufactured: 06/23/2021
• 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: Disability; Required Intervention; Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White