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

Catalog Number	0703001000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the neptune was mistakenly connected to a brain drain for 2-10 minutes, while on a low suction setting.The patient suffered a seizure post-op in pacu, which required no medical intervention.It was reported that the patient has a history of neurological issues; however, no history of seizures.It is unknown if the seizure was a result of the user error.

• Brand Name: NEPTUNE 3 ROVER (120V)
• Common Device Name: 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 24777245
• Report Number: 3015967359-2026-00207
• Device Sequence Number: 17658763
• Product Code: JCX
• UDI-Device Identifier: 07613327116656
• UDI-Public: (01)07613327116656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0703001000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown