MAUDE Adverse Event Report: COVIDIEN ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173052
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the laparoscopic inguinal hernia repair, when the reload was being changed, the plastic component of the reload snapped and broke.The broken part did not disengage from the device.The issue was resolved by replacing the device with a new tacker.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d3 (mfr name and address), d4 (udi#), d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that since the sulu was not received an rpa representative sulu p4c0888 was use for testing.The representative sulu was loaded into the instrument.The handle was actuated, and the tack deployed improperly and did not seat properly due to the disengaged e-piece.The condition of the instrument precludes a functional evaluation.It was reported that the plastic component of the reload snapped and broke.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 manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: for precise staple placement, pre-position the staple prior to firing.To pre-position the staple, squeeze the handle until you feel resistance.The staple legs will protrude from the tip of the nose.(do not continue squeezing the handle once the staple has been pre-positioned.) continuing to squeeze the handle will form the staple before placement on the tissue or mesh.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): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22022740
• Report Number: 2647580-2025-01528
• Device Sequence Number: 18303157
• Product Code: GCJ
• UDI-Device Identifier: 10884521070523
• UDI-Public: (01)10884521070523(17)290930(10)P4K1067
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 173052
• Device Catalogue Number: 173052
• Device Lot Number: P4K1067
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Patient Age: 56 YR
• Patient Sex: Male