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 Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e-sep safeair pencil activated without pressing any buttons by the surgeon.It was reported that the procedure was completed successfully.No information was available regarding how the issue was noticed, patient involvement, medical intervention or surgical delay.
Additional Manufacturer Narrative
D9: unknown if the device is available for return - the field will be updated once the information is provided.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• 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: 23050467
• Report Number: 3015967359-2025-01465
• Device Sequence Number: 9511973
• Product Code: GEI
• UDI-Device Identifier: 07613327117189
• UDI-Public: (01)07613327117189(17)271120(10)79917257
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 79917257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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