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

Catalog Number 0700001000

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility, the device plug sparked and had a flame.The procedure was completed successfully using back-up equipment.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.

Event Description

It was reported that during a surgical procedure at the user facility the device plug sparked and had a flame.The procedure was completed successfully using back-up equipment.No delay, no medical intervention, and no adverse consequences were reported with this 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: 4373764
• MDR Text Key: 5493639
• Report Number: 0001811755-2014-04778
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2004
• 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