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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 Patient Involvement (2645)
Event Date 10/01/2014
Event Type  malfunction  
Event Description
It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility, the device sparked when plugged in.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility, the device sparked when plugged in.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was evaluated and the reported event was confirmed.
 
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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 Key4205981
MDR Text Key4964723
Report Number0001811755-2014-03792
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,Followup
Report Date 10/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0700001000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/07/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/27/2003
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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