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

Model Number	133650
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Used covidien small clip applier 9.0" to for side branch vein clipping came out with twist and unable to retrieve from vein, torn vein side branch twice.Vein was not in pt at the time.Vein still able to be used for cabg [coronary artery bypass graft]; no harm to patient.

• Brand Name: PREMIUM SURGICLIP III
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 25825817
• Report Number: 25825817
• Device Sequence Number: 9814807
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: (01)10884521517394
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026
• Report Date (Section F): 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
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P5L0955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 49 KG
• Date Report Sent to FDA: 07/09/2026