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Adverse Event Report

ENCISION ENCISION L-DIAMOND ELECTRODE   back to search results
Lot Number ES-3511B
Patient Outcome  Other;
Event Description

The endo l diamond cauter electrode was being used by surgeon. About half way through procedure it began to arc. Quickly removed from pt. No known harm to pt. Cautery setting was at 80. After arc found 2 small holes in black covering zone one.

 
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Brand NameENCISION
Type of DeviceL-DIAMOND ELECTRODE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ENCISION
4828 steriling dr
boulder CO 80301
Device Event Key487985
MDR Report Key499218
Event Key473370
Report NumberMW1030310
Device Sequence Number1
Product CodeKNS
Report Source Voluntary
Report Date 08/21/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT NumberES-3511B
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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