MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp Smoke Evac. Pencil Coated RS,Non-Sterile; Electrosurgical cutting and coagulation device and accessories

Catalog Number	0703047002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use in a procedure at the user facility, a patient sustained a burn while using a smoke evac pencil.It was further reported that the noted wound required medical intervention.The wound was closed by the surgeon.It was further reported that the procedure was completed successfully, without delay.

• Brand Name: Smoke Evac. Pencil Coated RS,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 ; +353()214532900
• MDR Report Key: 50201872
• Report Number: 3015967359-2026-00455
• Device Sequence Number: 10336959
• Product Code: GEI
• UDI-Device Identifier: 07613327379471
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0703047002
• Device Lot Number: 86466334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/11/2026
• 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: Required Intervention
• Patient Sex: Unknown