MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE; APPARATUS, EXHAUST, SURGICAL

Catalog Number 0700001000

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that the neptune rover with smoke evac and power pole sparked when it was plugged in during repair at the user facility.There was no patient involvement and no adverse consequences associated with the device.

Event Description

It was reported that the neptune rover with smoke evac and power pole sparked when it was plugged in during repair at the user facility.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.

Manufacturer Narrative

The field service technician was able to confirm the reported event.The root cause was determined to be due to a loose wire in the power plug.This can result in sparking when plugged in or removed from the outlet.The technician replaced the power cord and the rover functioned as intended.

• 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 Key: 3673233
• MDR Text Key: 4226265
• Report Number: 0001811755-2014-00852
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0700001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1