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

Model Number 133650

Patient Problem Insufficient Information (4580)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

Small clip applier miss fired multiple times.Surgeon complained that it keeps happening with this brand of clip applier.

• Brand Name: PREMIUM SURGICLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17442115
• MDR Text Key: 320214296
• Report Number: 17442115
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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: P2M0067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2023
• Date Report to Manufacturer: 08/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1