MAUDE Adverse Event Report: COVIDIEN ENDO GIA 45MM TRI-STAPLE; STAPLER, SURGICAL

Model Number EGIA45AMT

Device Problem Defective Device (2588)

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

Event Date 02/15/2020

Event Type  malfunction  

Event Description

Per operating staff, device would not click into handle.Procedure - laparoscopic appendectomy.Add'l info received from nurse mgr."the device that malfunctioned was the reload that attaches to the insignia hand piece.Covidien endo gia 45mm tri-staple (ref # egia45amt, lot #p9d1535ky).The surgical team did open another hand piece and 45mm reload that was used on the surgical case.The malfunctioning device was not used on the pt." fda safety report id# (b)(4).

• Brand Name: ENDO GIA 45MM TRI-STAPLE
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9739720
• MDR Text Key: 180852575
• Report Number: MW5093178
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIA45AMT
• Device Lot Number: P9D1535KY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 76