MAUDE Adverse Event Report: COVIDIEN PREMIUM SURGICLIP II; CLIP, IMPLANTABLE

Model Number	134053
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that preoperatively, the clip could not be loaded, the jaws only closed when the handle was squeezed, which resulted in dry firing.There was no patient involved.
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: a1 additional information: 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 that the instrument was partially fired with eighteen clips remaining in the channel.One fully formed clip was jammed in the center of the clip channel preventing the clips from advancing.The ratchet function was engaged.Functional testing found that the formed clip could not be removed without causing damage to the instrument cover.It was reported that preoperatively, the clip could not be loaded, the jaws only closed when the handle was squeezed, which resulted in dry firing.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the user positions the instrument vertically and fires in air.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: PREMIUM SURGICLIP II
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24086314
• Report Number: 2647580-2026-00128
• Device Sequence Number: 9684035
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: (01)10884521057579(17)291130(10)P4M0923S(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143644
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P4M0923S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Patient Sex: Unknown