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

Model Number	134051
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medium clip did not fire correctly.The clip scissored and did not clamp the vessel properly.

• Brand Name: PREMIUM SURGICLIP II
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 25014561
• Report Number: 25014561
• Device Sequence Number: 21208783
• Product Code: FZP
• UDI-Device Identifier: 10884521057562
• UDI-Public: (01)10884521057562
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2026
• Report Date (Section F): 04/13/2026

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: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P5K0979
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2026
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 04/13/2026