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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN COVIDIEN; ENDO GIA STAPLER RELOAD
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COVIDIEN COVIDIEN; ENDO GIA STAPLER RELOAD Back to Search Results
Model Number EGIA45CTAVN
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Code Available (3191)
Event Date 07/20/2016
Event Type  Injury  
Event Description
During robotic video assisted thoracic surgery left lower lobectomy, the plastic yellow tiny piece broke off, discovered by surgeon inside thoracic cavity.This tiny piece broke out from the yellow shipped wedge of covidien 45 endo gia tan stapler reloaded, and fell into the cavity.Successfully removed by surgeon.No harm to pt.The yellow shipped wedge was removed from the stapler reload after being loaded to the stapler handle before the handle was closed, as per instruction from the company.This piece is really tiny, it is hard to find or be recognized.As further investigation, we found more broken yellow shipping wedges during others cases.It need to be attention to every users.Reason for use: left lung cancer.
 
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Brand Name
COVIDIEN
Type of Device
ENDO GIA STAPLER RELOAD
Manufacturer (Section D)
COVIDIEN
60 middletown avenue
north haven CT
MDR Report Key5843037
MDR Text Key51128293
Report NumberMW5063804
Device Sequence Number1
Product Code GAG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model NumberEGIA45CTAVN
Device Catalogue NumberEGIA45CTAVN
Device Lot NumberN6FO112KX
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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