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

Model Number	133650
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Mechanics Altered (2984)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5, g3, h6 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
According to the reporter, intra-operatively, when the clips of four clip appliers were closed, the clips reopened not maintaining closure.Clips fell into the patient's cavity and were removed with forceps.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: 133650, 133650 premium surgiclip iii 9.0 (lot#p5j0978); 133650, 133650 premium surgiclip iii 9.0 (lot#p5h1169); 133650, 133650 premium surgiclip iii 9.0 (lot#p5h1137); 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
According to the reporter, four clip appliers had issues.When the clips were closed, the clips reopened not maintaining closure.Additionally, for two of the four clip appliers, the handles were squeezed but there were issues with firing or loading the clips.The fourth clip applier also had malformed clips.

• Brand Name: PREMIUM SURGICLIP III
• 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: 24903715
• Report Number: 2647580-2026-01067
• Device Sequence Number: 9800236
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: (01)10884521517394(17)300831(10)P5J0978
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P5J0978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 09/09/2025
• 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: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown