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

Model Number 176630

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

Md reported to surgical tech of a clip miss fire produced malfunctioned.It was quickly replaced to complete surgery successfully.Post op the malfunctioning produced was boxed, bagged and labled with patient id and given to department director.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17718664
• MDR Text Key: 323050073
• Report Number: 17718664
• 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: 09/08/2023,09/07/2023

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 Lot Number: J3B0826Y
• 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: 09/08/2023
• Date Report to Manufacturer: 09/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8395 DA