NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE 0700001000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-16 for NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE 0700001000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[15346952] It was reported that during setup prior to a surgical procedure at the user facility the device was sparking when it was plugged in. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[15742187] Evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10


[18068752] It was reported that during setup prior to a surgical procedure at the user facility the device was sparking when it was plugged in. No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[18646833] The root cause was determined to be due to the power plug? Heat/melting. Based on the risk documentation, this can occur if the live leads are loose inside the plug due to the plug being damaged. Based, on the risk documentation, this same thing can result in the plug sparking when plugged into or removed from the outlet. The technician replaced the power cord and the rover functioned as intended.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001811755-2015-00928
MDR Report Key4602581
Report Source06
Date Received2015-03-16
Date of Report2015-02-16
Date of Event2015-02-12
Date Mfgr Received2015-04-09
Device Manufacturer Date2002-08-01
Date Added to Maude2015-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. CASEY METZGER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
Generic NameAPPARATUS, EXHAUST, SURGICAL
Product CodeFYD
Date Received2015-03-16
Catalog Number0700001000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-16

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