MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NEPTUNE 3 ROVER (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number 0703001000

Device Problem Inadequate Filtration Process (2308)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that during a procedure at the user facility, the smoke evacuator failed during a case.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: NEPTUNE 3 ROVER (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13026442
• MDR Text Key: 282405033
• Report Number: 3015967359-2021-02729
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 07613327116656
• UDI-Public: 07613327116656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0703001000
• Device Catalogue Number: 0703001000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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