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

Model Number	TRIEEAXL28XT
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: trieeaxl28xt - cir stplr trieeaxl28xt blk ext, lot# p3j0939.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 low anterior resection (lar), in colon resection when creating the anastomosis with the circular stapler, the surgeon was unsure if the device had initially fired.However, the stapler and anvil remained attached to the colon/rectum and would not release.The surgeon attempted to open the stapler to remove it, but it remained stuck.To resolve the issue, the surgeon closed the stapler and fired it again to release the tissue.A second stapler was utilized to create a successful anastomosis that was leak tested successfully.The patient was recovering well within 48 hours of the procedure.On the eight-day post-operation, the patient was treated for incision rupture and pain.Subsequent evaluation concluded a probable anastomotic leak.During an open exploratory laparotomy, it was discovered the anastomosis created had failed.The patient had tissue damage as more colon had to be removed, the sigmoid colon was removed.A colostomy was performed, and a temporary colostomy bag was required to establish bowel function.The patient's hospitalization was extended as well.
Event or Problem Description
According to the reporter, during an exploratory laparotomy colon resection, in colon resection when creating the anastomosis with the circular stapler, the surgeon was unsure if the device had initially fired.However, the stapler and anvil remained attached to the colon/rectum and would not release.The surgeon attempted to open the stapler to remove it, but it remained stuck.To resolve the issue, the surgeon closed the stapler and fired it again to release the tissue.A second stapler was utilized to create a successful anastomosis that was leak tested successfully.The patient was recovering well within 48 hours of the procedure.On the eight-day post-operation, the patient was treated for incision rupture and pain.Subsequent evaluation concluded a probable anastomotic leak.During an open exploratory laparotomy, it was discovered the anastomosis created had failed.The patient had tissue damage as more colon had to be removed, the sigmoid colon was removed.A colostomy was performed, and a temporary colostomy bag was required to establish bowel function.The patient's hospitalization was extended as well.
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
Additional information: g3, h3, h6 h3 evaluation summary: 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 device was difficult to remove from cavity.The reported issue could not be 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: 19442014
• Report Number: 2647580-2024-02441
• Device Sequence Number: 8455997
• Product Code: GAG
• UDI-Device Identifier: 10884521593138
• UDI-Public: 10884521593138
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024

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: TRIEEAXL28XT
• Device Catalogue Number: TRIEEAXL28XT
• Device Lot Number: P3J0939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 07/17/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 06/06/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 51 YR
• Patient Sex: Female