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

Model Number 176657

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

Device trigger did not retract after priming clip prior to use.Trigger had to be manually retracted after each clip was primed adding an extra motion to the use of said item.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13839075
• MDR Text Key: 287536813
• Report Number: 13839075
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J2A0077NY
• 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: 03/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female