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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MULTIFIRE ENDO GIA STAPLER, SURGICAL

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COVIDIEN MULTIFIRE ENDO GIA STAPLER, SURGICAL Back to Search Results
Catalog Number 030811
Device Problems Sticking (1597); Failure to Fire (2610)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2016
Event Type  Malfunction  
Event Description

The latch was sticking, it would not fire on a multifire endo device.

 
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Brand NameMULTIFIRE ENDO GIA
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN
60 middletown ave.
north haven CT 06473
MDR Report Key6185121
MDR Text Key62716808
Report Number6185121
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/18/2016,11/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date11/30/2020
Device Catalogue Number030811
Device LOT NumberPSL0259X
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2016
Event Location Hospital
Date Report TO Manufacturer11/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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