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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Bovie smoke evacuator was plugged into bovie machine to be used during the case but when the surgeon went to use bovie it did not emit electricity.Bovie was replaced with a new one and new bovie worked.

• 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: 22826762
• Report Number: 22826762
• Device Sequence Number: 4463876
• Product Code: GEI
• UDI-Device Identifier: 07613327117189
• UDI-Public: (01)07613327117189
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/12/2025
• Report Date (Section F): 08/12/2025

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: 79599413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 08/12/2025