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

Model Number 176630

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Event Description

Patient undergoing a gastric sleeve procedure.During the case the endo clip applier (ref # (b)(4), lot #j9f0644y) did not function correctly, the clips would not advance.The device was removed from the field and replaced with another device that functioned without incident.No patient harm.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9952954
• MDR Text Key: 187434239
• Report Number: 9952954
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: (01)10884521057852(17)220531(10)J9F0644Y
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2020

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 Operator: Health Professional
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9F0644Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 125