MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP II; CLIP, IMPLANTABLE

Model Number	134053
Medical Device Problem Codes	Mechanical Problem (1384); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a cardiovascular open-heart surgery, during vascular processing, the two-clip applier was not loading properly.There was clip malformation and twisting, and the product was replaced.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: (b)(6) premium surgiclip iii 9.0 (lot#p4k1244).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
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 fully fired.The ratchet function was engaged.The distal end of the channel cover was intact.Microscopic inspection of the jaw co-planarity and evaluation also noted that the interlock was returned engaged and prevented the jaws from approximating.It was reported that the device was not loading properly and there was clip malformation.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22196395
• Report Number: 2647580-2025-01816
• Device Sequence Number: 8593922
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: 10884521057579
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/13/2025

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: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P5A1063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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