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

Catalog Number 0702001000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/11/2015

Event Type  Injury  

Event Description

It was reported that following a surgical procedure at the user facility, a small piece of metal was observed in the waste canister.An x-ray was performed on the patient to verify there was no piece in the patient.The radiologist confirmed the x-ray was negative for any signs of debris in the patient.The procedure was completed successfully.No further information regarding this event is available from the user facility.

Event Description

It was reported that following a surgical procedure at the user facility, a small piece of metal was observed in the waste canister.An x-ray was performed on the patient to verify there was no piece in the patient.The radiologist confirmed the x-ray was negative for any signs of debris in the patient.The procedure was completed successfully.No further information regarding this event is available from the user facility.

Manufacturer Narrative

Upon inspection of the device by a field service representative, the reported event was not able to be confirmed.The device was serviced for preventive maintenance and returned to service at the user facility.

• 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: 4586300
• MDR Text Key: 19350882
• Report Number: 0001811755-2015-00844
• 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: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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