MAUDE Adverse Event Report: COVIDIEN LP MULTIFIRE PREMIUM; STAPLE, REMOVABLE (SKIN)

Model Number 059037

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

When using the stapler, it misfired and stopped working properly.

• Brand Name: MULTIFIRE PREMIUM
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13250423
• MDR Text Key: 283768406
• Report Number: 13250423
• Device Sequence Number: 1
• Product Code: GDT
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 059037
• Device Catalogue Number: 059037
• Device Lot Number: JIE2414X
• 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: 01/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female