MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Tissue Breakdown (2681)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature source of study, a retrospective study outcome of the evaluation of the safety and performance of medtronic endo universal 65 in elective laparoscopic inguinal, umbilical, epigastric and incisional hernia operations (1 year follow-up).1.351 (92.28 %) patients in elective laparoscopic inguinal hernia repair, 36 (2.46 %) patients in elective laparoscopic umbilical hernia repair, 7 (0.48 %) patients in elective laparoscopic epigastric hernia repair and 70 (4.78 %) patients in elective laparoscopic incisional hernia repair were included in the study.Tissue breakdown (intraoperative organ injuries) is a complication.Post operative complications included bleeding, seroma, infection, pain and hernia recurrence are device related.Additional surgery was required.General complications and complication related reoperations are not related to the device.Herniamed registry extraction medtronic endo universal 65 in elective laparoscopic inguinal, umbilical, epigastric and incisional hernia operations (1 year follow-up), dr.(b)(6).
Additional Manufacturer Narrative
D10 concomitant products: 173054, 173054 endo uni 12 with (lot#:unknown) ferdinand, köckerling md."herniamed registry extraction medtronic endo universal 65 in elective laparoscopic inguinal, umbilical, epigastric and incisional hernia repair (1-year follow-up)", issue v00, 04jan2024.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: g3, literature file attached 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 UNIVERSAL 65
• 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: 20025919
• Report Number: 2647580-2024-03654
• Device Sequence Number: 15294868
• Product Code: GCJ
• UDI-Device Identifier: 10884521070530
• UDI-Public: 10884521070530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 173054
• Device Catalogue Number: 173054
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown