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

Model Number	174007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that postoperatively of a bilateral transabdominal preperitoneal (tapp) inguinal hernia laparoscopic procedure, an adhesion of the clip to the bowel occurred after the procedure.Medical or surgical intervention was needed to remove the adhesion to prevent a permanent impairment of a function.The adherence of the clip to the bowel was resolved by removing the adhesion.
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: h6 (imf) additional information: g3.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: b5, d1, d4 (model #, catalog #, expiration date, lot #, unique identifier (udi)), g3, h4, 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that postoperatively of a bilateral transabdominal preperitoneal (tapp) inguinal hernia laparoscopic procedure, an adhesion of the clip to the bowel occurred after the procedure.Medical or surgical intervention was needed to remove the adhesion to prevent a permanent impairment of a function.The adherence of the clip to the bowel was resolved by removing the adhesion.The patient was re-operated in another hospital.The surgeon removed the staples that had come undone.
Additional Manufacturer Narrative
Additional information: e4, g3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the first photo depicts two tacks, one appears to be malformed.The second photo depicts a malformed tack.The third photo depicts a malformed tack.The fourth photo depicts a line of tacks in tissue with what appears to be malformed tacks.The fifth photo depicts a line of tacks with what appears to be malformed tacks.It was reported that an adhesion of the clip to the bowel occurred after the procedure the reported issue was confirmed.The most likely cause could not be established from the information available.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: 21602779
• Report Number: 2647580-2025-00825
• Device Sequence Number: 13065317
• Product Code: GCJ
• UDI-Device Identifier: 10884521070547
• UDI-Public: 10884521070547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/21/2025

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: 174007
• Device Catalogue Number: 174007
• Device Lot Number: P4J0795
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 03/13/2025; 06/19/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/17/2025; 03/18/2025; 06/21/2025
• Date Device Manufactured: 09/03/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown