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Adverse Event Report

ETHICON ENDO SURGERY, INC. ETS FLEX 45 ENDO STAPLER   back to search results
Model Number ETS FLEX 45
Patient Outcome  Other;
Event Description

Staple gun misfired. Surgeon did interrupted stitches on the remnant with staples.

 
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Brand NameETS FLEX 45
Type of DeviceENDO STAPLER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ETHICON ENDO SURGERY, INC.
4545 creek rd
cincinnati OH 45242 2839
Device Event Key505007
MDR Report Key515990
Event Key489571
Report NumberMW1031392
Device Sequence Number1
Product CodeKOG
Report Source Voluntary
Report Date 03/01/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/01/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberETS FLEX 45
Device LOT NumberMAY BE ON INSTRUMENT
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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