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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. SELECTOR 24KHZ NEURO SHORT HANDPIECE
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INTEGRA NEUROSCIENCES, LTD. SELECTOR 24KHZ NEURO SHORT HANDPIECE Back to Search Results
Catalog Number 1523000M7
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2014
Event Type  malfunction  
Event Description
It was reported that a cusa selector 24khz handpiece (out of box) irrigation fluid was leaking out of the base.The pt was on the operating room table anesthetized when the staff discovered that the handpiece was leaking.The procedure was underway, however, it was while setting up the equipment (putting the handpiece together) before the handpiece was used on the pt that it was noted that the unit was leaking.Type of procedure: spinal cord tumor excision.There was a surgical delay of one hour as a result of this problem, however, the pt did not incur an injury as a result of the delay.The surgery was completed by switching to an old cusa.
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.
 
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Brand Name
SELECTOR 24KHZ NEURO SHORT HANDPIECE
Type of Device
NA
Manufacturer (Section D)
INTEGRA NEUROSCIENCES, LTD.
andover hampshire S910 4DR
UK  S9104DR
Manufacturer Contact
315 enterprise dr
6099365560
MDR Report Key3855483
MDR Text Key4411788
Report Number8010219-2014-00015
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1523000M7
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2014
Initial Date FDA Received04/17/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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