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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN CEEA 28 STAPLING DEVICE

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COVIDIEN CEEA 28 STAPLING DEVICE Back to Search Results
Model Number CEEA 28
Device Problems Failure to Fire (2610); Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 01/22/2016
Event Type  Injury  
Event Description

Surgeon was using the ceea 28 to do an anastomosis, she already had the stapler in place and clamped down but had not fired (stapled ) it yet, she tried to disengage it but was not able to. The instrument was jammed, the company rep was called in. Chief of surgery was called in as well and he scrubbed in and was able to disengage it using a hemostat. They were then able to fire this stapler without incident and was able to disengage and remove. Covidien ceea 28 lot # p5j0869. Instrument was taken by the rep.

 
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Brand NameCEEA 28
Type of DeviceSTAPLING DEVICE
Manufacturer (Section D)
COVIDIEN
minneapolis MN 55432
MDR Report Key5403644
MDR Text Key37352910
Report NumberMW5059824
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 01/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCEEA 28
Device LOT NumberP5J0869
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2016
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? Yes
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/28/2016 Patient Sequence Number: 1
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