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U.S. Department of Health and Human Services

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

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COVIDIEN LLC GIA DEVICE GIA8048 STAPLING DEVICE Back to Search Results
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.

 
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Brand NameGIA DEVICE GIA8048
Type of DeviceSTAPLING DEVICE
Manufacturer (Section D)
COVIDIEN LLC
minneapolis MN 55432
MDR Report Key5416617
MDR Text Key37783002
Report NumberMW5060033
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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  
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGIA8048M
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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