MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 SPECIMEN COLLECTION 4-PORT MANIFOLD; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number	0702020001
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by customer.
Event or Problem Description
It was reported by the customer that during a general surgery procedure with dr.(b)(6) the neptune exhibited suction lower than expected or desired.The customer feels it's probably an issue with manifold, commenting that lots of chips (bone) might have clogged the manifold basket.The customer reported the device was being used for fluid collection.The customer commented that as part of their workflow, rovers can cross over from general cases to neuro cases.A manifold clogging could lead to inadequate visibility to the surgical field during a hemorrhage.The procedure was completed successfully with no known impact or adverse consequences to the patient that were reported with this event.

• Brand Name: NEPTUNE 2 SPECIMEN COLLECTION 4-PORT MANIFOLD
• 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: 7330089
• Report Number: 0001811755-2018-00501
• Device Sequence Number: 1592157
• Product Code: JCX
• UDI-Device Identifier: 37613154733225
• UDI-Public: (01)37613154733225
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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: 0702020001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1