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Adverse Event Report

ETHICON ENDO-SURGERY, INC. 75 MM PROXIMATE LINEAR STAPLER   back to search results
Catalog Number CAT TLC75
Event Date 03/01/2004
Patient Outcome  Other;
Event Description

There was "difficulty pulling down knife and the stapler wouldn't fire" while pt was undergoing esophagectomy. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.

 
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Brand Name75 MM PROXIMATE LINEAR STAPLER
Type of DeviceSTAPLER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC.
4545 creek road
cincinnati OH 45242
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.
4545 creek road
cincinnati OH 45242
Device Event Key511617
MDR Report Key522487
Event Key495862
Report Number522487
Device Sequence Number1
Product CodeGAG
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/01/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAT TLC75
Device LOT NumberV4Z791
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2004
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Event Location Hospital
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on December 31, 2008

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