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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ENDO GIA STAPLER, SURGICAL

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COVIDIEN ENDO GIA STAPLER, SURGICAL Back to Search Results
Model Number EGIAUSTND
Device Problems Difficult to Insert (1316); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2016
Event Type  Malfunction  
Event Description

Stapler would not accept staple load and trigger would not pull during surgery. A second stapler and load were opened to complete procedure. Manufacturer response for endo gia articulating reload, endo gia articulating reload (per site reporter): manufacturer provided rga# and product return packaging. Manufacturer response for endo gia ultra universal stapler, covidien (per site reporter): manufacturer provided rga# and product return packaging.

 
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Brand NameENDO GIA
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN
60 middletown ave.
north haven CT 06473
MDR Report Key6198063
MDR Text Key63082190
Report Number6198063
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 12/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberEGIAUSTND
Device Catalogue NumberEGIAUSTND
Device LOT NumberP6J0443X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2016
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer12/07/2016
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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