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	Burn(s) (1757)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure, the e-sep pencil activated without the buttons being pushed and the patient got burned.The pencil was plugged into the generator and activated without either of the buttons being deployed.The pencil was removed from the field and a new one was provided.The procedure was completed successfully; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Correction b5: event details updated based on the provided information h6: health impact code updated based on the provided information additional information d4: lot number added d4: full udi added.
Event or Problem Description
It was reported that during a procedure, the e-sep pencil activated without the buttons being pushed and the patient got burned.The pencil was plugged into the generator and activated without either of the buttons being deployed.The pencil was removed from the field and a new one was provided.It was further reported that the burn was treated with marcaine and dermabond to prevent infection.The procedure was completed successfully.It was further reported that the user did not use a holster while the pencil was not in use.

• 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: 19780486
• Report Number: 3015967359-2024-01278
• Device Sequence Number: 8428999
• Product Code: GEI
• UDI-Device Identifier: 07613327379488
• UDI-Public: (01)07613327379488(17)260609(10)70888646
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/28/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0703046002
• Device Lot Number: 70888646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 04/28/2025
• 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