MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PUSH-BUTTON SMOKE EVAC. PENCIL, COATED; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703046000
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: full udi will be filed once the product history review is provided.
Event or Problem Description
It was reported that the patient¿s skin was burned.No further details have been provided regarding what cause the burn.The user facility stated that no medical intervention was required.It was further reported that the procedure was completed successfully without a delay.Additional information is currently being requested.
Additional Manufacturer Narrative
B5: event details updated based on the provided information.During the investigation, it was confirmed that a non stryker electrode was used, which caused a patient burn.The burn was minor and did not require medical intervention.Based on this information, the event is not reportable.D4: added lot number and full udi.H6: device code updated based on complaint investigation.
Event or Problem Description
According to additional information provided, the non-stryker electrode was used during the surgery.

• Brand Name: PUSH-BUTTON SMOKE EVAC. PENCIL, COATED
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 23679415
• Report Number: 3015967359-2025-01688
• Device Sequence Number: 9761113
• Product Code: GEI
• UDI-Device Identifier: 07613327117189
• UDI-Public: (01)07613327117189(17)270430(10)76938462
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143145
• 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,Followup
• Report Date (Section B): 04/01/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0703046000
• Device Lot Number: 76938462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown