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

Catalog Number 176625

Device Problems Misfire (2532); Failure to Fire (2610); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

Surgeon fired clip applier one time and it misfired.It was given back to the tech to evaluate and the device jammed would not fire.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11912379
• MDR Text Key: 253556693
• Report Number: 11912379
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2021

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 Catalogue Number: 176625
• Device Lot Number: J8K0906NX
• 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: 05/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 69