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

Model Number 176620

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

Endo clip applier defective - unable to load clip during day surgery.Manufacturer representative aware of the event and that the device is available.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11222284
• MDR Text Key: 241237228
• Report Number: 11222284
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176620
• Device Catalogue Number: 176620
• 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: 01/18/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Weight: 64