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

Model Number 176630

Device Problems Failure to Fire (2610); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Endo clip¿ iii 5 mm single use clip applier not firing and closing clips correctly (ref# 176630, lot #j1g0106y).

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13051662
• MDR Text Key: 282567104
• Report Number: 13051662
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176630
• Device Lot Number: J1G0106Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female