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

Model Number	134053
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Mechanics Altered (2984); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 134053, 134053 premium surgiclip ii 11.5, (lot # p5h1015) 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 a premium clip applier was used during an open mastectomy and reconstruction with flaps when the physician attempted to clip vessels during the mastectomy.A clip loading or firing issue was reported, and the clips were described as malformed in a y-shape when released/deployed.Clips were reported to have disengaged and fallen into the patient cavity after deployment; the clips were visible and were retrieved with an instrument.To complete the procedure, another device from the same lot was opened and had the same issue, and then another clip applier from a different lot was opened and worked as intended.No patient complications have been reported as a result of this event.

• 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: 25403200
• Report Number: 2647580-2026-01614
• Device Sequence Number: 16027898
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: (01)10884521057579(17)300731(10)P5H1015
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: P5H1015
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 08/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown