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

Model Number	173052
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 a laparoscopic gastric bypass, while on the last step of the procedure and when closing the mesentery, the surgeon was unable to squeeze the handle.To resolve the issue and complete the case, a new device was used.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d3 (mfr name, street1), d4 (udi), d9, g3, h3, 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 partially disengaged from the device on one side.There was evidence of weld on the device.The single use loading unit (sulu) was not received.A tack was jammed in the distal end of the shaft.During evaluation, the handle was actuated, and the tack deployed improperly and did not seat properly due to the disengaged e-piece.It was reported that the surgeon was unable to squeeze the handle.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur as a result of excessive manipulation of the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 21714435
• Report Number: 2647580-2025-00965
• Device Sequence Number: 9941698
• Product Code: GCJ
• UDI-Device Identifier: 10884521070523
• UDI-Public: (01)10884521070523(17)290731(10)P4H0959
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: P4H0959
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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 Sex: Unknown