MAUDE Adverse Event Report: COVIDIEN CEEA 28; STAPLING DEVICE

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.

• Brand Name: CEEA 28
• Type of Device: STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN; minneapolis MN 55432
• MDR Report Key: 5403644
• MDR Text Key: 37352910
• Report Number: MW5059824
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CEEA 28
• Device Lot Number: P5J0869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR