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 Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that prior to a surgical procedure at the user facility, the plug of the rover was sparking when plugged in.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported sparking of the plug was confirmed by a manufacturer field repair technician.Upon inspection, it was found that the power plug was damaged which can lead to the reported event.

• 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: 4218214
• MDR Text Key: 5000934
• Report Number: 0001811755-2014-03889
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• 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
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2004
• 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