MAUDE Adverse Event Report: STRYKER INSTRUMENTS NEPTUNE E-SEP; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	0703046000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Bovie was plugged into machine properly but did not function out of package.

• Brand Name: NEPTUNE E-SEP
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 23756205
• Report Number: 23756205
• Device Sequence Number: 10170856
• Product Code: GEI
• UDI-Device Identifier: 07613327117189
• UDI-Public: (01)07613327117189(17)280121(10)80676453
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/05/2025
• Report Date (Section F): 11/05/2025

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
• Device Model Number: 0703046000
• Device Catalogue Number: 0703-046-000
• Device Lot Number: 80676453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Date Report Sent to FDA: 11/05/2025