MAUDE Adverse Event Report: COVIDIEN ENDO GIA; STAPLER, SURGICAL

Catalog Number EGIAUXL

Device Problems Misfire (2532); Noise, Audible (3273)

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

Event Date 02/23/2017

Event Type  malfunction  

Event Description

When the registered nurse first assistant was firing the stapler there was a "cracking sound" and stapler did not finish firing.Multiple handles and staples were opened and all did same thing.

• Brand Name: ENDO GIA
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 7032815
• MDR Text Key: 92513110
• Report Number: 7032815
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2017

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: Nurse
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: EGIAUXL
• Device Lot Number: P6I0155X
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68