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

Catalog Number	0703046002
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number of the device is unknown - full udi is not available.
Event or Problem Description
It was reported that the e-sep safeair pencil activated without the surgeon pressing any buttons.It was reported that the patient was burned by the pencil that was resting on the patient.It was further reported that the burn did not require medical intervention.It was further reported that the procedure was completed successfully, without significant delay.
Additional Manufacturer Narrative
D9: device not returned for evaluation.
Event or Problem Description
No new information.

• Brand Name: SMOKE EVAC. PENCIL COATED PB,NON-STERILE
• 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: 23233313
• Report Number: 3015967359-2025-01508
• Device Sequence Number: 15671681
• Product Code: GEI
• UDI-Device Identifier: 07613327379488
• UDI-Public: (01)07613327379488
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 0703046002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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
• Patient Sex: Unknown