MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 0702001000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

It was reported that waste fluid sprayed back out of the suction tubing of the neptune 2 rover ultra after a procedure.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

The reported backflow was not able to be confirmed by a manufacturer repair technician through functional evaluation.A potential cause for the reported event is the manifold being seated incorrectly.The device was serviced for preventive maintenance by a manufacturer field service representative at the user facility.

Event Description

It was reported that waste fluid sprayed back out of the suction tubing of the neptune 2 rover ultra after a procedure.There was no patient involvement and no adverse consequences associated with the device.

• Brand Name: NEPTUNE 2 ROVER ULTRA (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• 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: 3929086
• MDR Text Key: 16563758
• Report Number: 0001811755-2014-02466
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132671
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2009
• 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