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

Catalog Number	0702014000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a neptune docker's hose was leaking at the user facility prior to the start of a surgical procedure.Two surgical cases were canceled as a result of the reported event.No medical intervention and no adverse consequences were reported in regards to the event.All cases that were canceled were rescheduled with no impact to the patient.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that a neptune docker's hose was leaking at the user facility prior to the start of a surgical procedure.Two surgical cases were canceled as a result of the reported event.No medical intervention and no adverse consequences were reported in regards to the event.All cases that were canceled were rescheduled with no impact to the patient.

• Brand Name: NEPTUNE 2 DOCKING STATION (120V)
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7838307
• Report Number: 0001811755-2018-01633
• Device Sequence Number: 1287378
• Product Code: JCX
• UDI-Device Identifier: 07613154559053
• UDI-Public: 07613154559053
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0702014000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1