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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  
Manufacturer Narrative

The trigger-flex intended use is to ablate disc tissue. During intended use, access to the disc is gained with a trephine and then the trigger-flex is inserted through an endoscope channel so that the activated trigger-flex tip is in contact with the tissue to be ablated. In this surgery, the trigger-flex bipolar probe was used to mechanically "enter the disc" as opposed to using a trephine. It has been determined that this action caused the tip to break. We have reviewed the procedure video which confirmed the misuse and resultant failure. Conclusion and analysis: the units were tested in the chicken meat model under much more severe conditions than they would be subjected to during normal clinical use due to the extended times (e. G. Greater than 2 minutes). Some samples were also subjected to the higher power than would normally be experienced during normal clinical use. Even under the extreme conditions that the samples were subjected to, the breaking off of an electrode tip was never observed. Furthermore, when the electrodes were subjected to the pull test, they all failed at greater than 23 lbs. This is significantly higher than would be experienced during normal clinical use. It is also noteworthy that the used samples did not break at significantly lower forces than the unused samples, indicating that use in extreme conditions does not significantly adversely affect the strength of the electrodes.

 
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 When the instrument was withdrawn, and it was realized that the tip had broken, the c-arm was used to locate the tip fragment.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 F)
ELLIQUENCE, LLC
oceanside NY
Manufacturer (Section D)
ELLIQUENCE, LLC
oceanside NY
Manufacturer Contact
marc somelofski
3333 royal avenue
oceanside , NY 11572
(516) 594 -3333
Device Event Key2219378
MDR Report Key2190177
Event Key2087113
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
Was The Report Sent To Manufacturer? No
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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