MAUDE Adverse Event Report: COVIDIEN LLC GIA DEVICE GIA8048; STAPLING DEVICE

Model Number GIA8048M

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  malfunction  

Event Description

Covidien gia device gia8048m (reload gia8048l) failed to fire.There was no injury to the patient.Patient safety report.

• Brand Name: GIA DEVICE GIA8048
• Type of Device: STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN LLC; minneapolis MN 55432
• MDR Report Key: 5416617
• MDR Text Key: 37783002
• Report Number: MW5060033
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIA8048M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR