MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174025
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 174025 mf endo hernia 0 4.8 stap x6 - 174025, lot#: p3m0945 unknown versastep - unknown versast, 174007 mf endo hernia dlu 4.8mm x6 - 174007, lot#: p4g1036.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 hernia repair procedure, the first stapler was firing but the staples were not closing fully.A staple reload was used to determine whether the problem was with the cartridge or the gun but the staples would not close fully so a second gun was opened.When the device was inserted into the patient and the handle pressed, the staple cartridge ejected into the cavity and had to be retrieved.The surgeon tried it a few times outside the cavity again and the same thing happened.A third stapler was used to resolve the issue.The patient was kept longer under anesthetics for about fifteen minutes longer while this was being sorted.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h#, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the e-piece was disengaged from the device.The broken lower cover tube was separated under the sulu.There was evidence of weld on the device.The sulu was received attached to the device with seven tacks remaining.It was reported that there was a staple formation issue.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur by not completing the firing cycle and trying to remove the reload with excessive force resulting in the disengaged e-piece.The damaged cover tube condition may occur when the firing handle is not completely cycled and trying to remove the dlu incorrectly during the incomplete firing cycle.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: MULTIFIRE ENDO HERNIA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 21566003
• Report Number: 2647580-2025-00774
• Device Sequence Number: 15853457
• Product Code: GCJ
• UDI-Device Identifier: 10884521070592
• UDI-Public: 10884521070592
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K912097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 174025
• Device Catalogue Number: 174025
• Device Lot Number: P3M0945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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: 64 YR
• Patient Sex: Male