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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELLIQUENCE, LLC BIPOLAR TRIGGER-FLEX PROBE TRIGGER-FLEX BIPOLAR SYSTEM

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ELLIQUENCE, LLC BIPOLAR TRIGGER-FLEX PROBE TRIGGER-FLEX BIPOLAR SYSTEM Back to Search Results
Catalog Number DTF-40
Event Date 04/21/2008
Event Type  Injury  
Event Description

The trigger-flex bipolar probe was used to mechanically "enter the disc" during an endoscopic spine procedure instead of using a trephine. This action caused the tip of the probe to break. When the instrument was withdrawn, and it was realized that the tip had broken, the c-arm was used to locate the tip fragment. The fragment was then removed via an endoscopic grasping forceps from within the patient. The patient suffered no adverse reaction.

 
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Brand NameBIPOLAR TRIGGER-FLEX PROBE
Type of DeviceTRIGGER-FLEX BIPOLAR SYSTEM
Manufacturer (Section D)
ELLIQUENCE, LLC
oceanside NY
Manufacturer Contact
marc somelofski
3333 royal avenue
oceanside , NY 11572
5165943333
MDR Report Key2190177
Report Number3007024186-2008-00001
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/27/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/04/2011
Device Catalogue NumberDTF-40
Device LOT Number080101294
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/25/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/25/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/27/2008 Patient Sequence Number: 1
Treatment
SYSTEM
RICHARD WOLF MEDICAL INSTRUMENT'S ENDOSCOPIC
ELLMAN SURGI-MAX
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