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

Model Number 134051

Device Problems Failure to Fire (2610); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Multiple complaints that the clip applier won't fire or when it does it doesn't squeeze the tissue in the correct manner.Clip applier was not used and another was brought into the case.

• Brand Name: PREMIUM SURGICLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 17181157
• MDR Text Key: 317669614
• Report Number: 17181157
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• 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: P3C0356
• 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: 06/13/2023
• Date Report to Manufacturer: 06/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Sex: Female