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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE; APPARATUS, EXHAUST, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE; APPARATUS, EXHAUST, SURGICAL Back to Search Results
Catalog Number 0700001000
Device Problem Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2014
Event Type  malfunction  
Event Description
It was reported that the device sparks when it is plugged in.There were no adverse consequences associated with this event.
 
Manufacturer Narrative
The field service technician found that the hot wire was loose causing a spark.The technician tightened all connections on the plug and returned the unit to service.
 
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Brand Name
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
Type of Device
APPARATUS, EXHAUST, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3628098
MDR Text Key20106621
Report Number0001811755-2014-00474
Device Sequence Number1
Product Code FYD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0700001000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/31/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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