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

Model Number	134051
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
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 procedure, the clip did not come out.A new device was used to complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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 the instrument was partially applied with clips remaining.One partially formed clip was returned in the jaws.The clip was removed prior to functional evaluation.The ratchet function was engaged.The distal end of the channel cover was intact.Microscopic inspection of the jaw co-planarity.Functional testing found that the ratchet function was disengaged.The instrument was cycled to load the next clip, but the clip did not enter the jaws.The clip was removed manually and the instrument was cycled again, no clip was loaded into the jaws.Upon inspection of the instrument, it was observed that the pusher bar was unable to fully retract or extend.Microscopic inspection of the pusher bar revealed damage.It was reported that the lip did not come out.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when the jaws of the instrument are constrained or with a side load to the jaws while attempting to fire a clip.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: squeeze the handles together firmly as far as they will go.As the handles are squeezed, the clip is held firmly by the jaw and closed around the tissue.Failure to squeeze the handles completely can result in clip malformation and possible bleeding or leakage.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: 23638372
• Report Number: 2647580-2025-03491
• Device Sequence Number: 9841484
• Product Code: FZP
• UDI-Device Identifier: 10884521057562
• UDI-Public: (01)10884521057562(17)300331(10)P5D0850
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P5D0850
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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