MAUDE Adverse Event Report: STRYKER CORPORATION NEPTUNE 3 WASTE MANAGEMENT; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

Stryker neptune 3 waste management 12 vac rover suction device did not work properly during a surgical procedure.There may be a design flaw, suction is in close proximity to smoke evacuator.If wet, filter will turn off device during a surgical procedure.Which can result in a very bloody body fluid field that can obstruct the surgical site.Fda safety report id# (b)(4).

• Brand Name: NEPTUNE 3 WASTE MANAGEMENT
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERE
• Manufacturer (Section D): STRYKER CORPORATION
• MDR Report Key: 15515471
• MDR Text Key: 301029060
• Report Number: MW5112336
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other