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

Catalog Number	0703047000
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
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 use at the user facility, the device unintentionally activated, causing a burn to the patient's bowel.It was further reported that the burn required medical intervention, suture repair.It was further reported that the staff surgeon also received a burn to his left forearm as the cautery was on without the button being pushed.It was further reported that the user did not use a holster while the pencil was not in use.It was further reported that the procedure was completed successfully, without significant delay.
Additional Manufacturer Narrative
Correction: h6: component code grid changed based on the investigation results additional information: b5: event details updated based on the provided additional information.
Event or Problem Description
According additional information provided, the e-sep pencil was used parallel to and in close proximity with two other electrical devices.It was further reported that the power setting was increased from coag 30/40, cut 30 to coag 60¿80 during the procedure.

• Brand Name: ROCKER-SWITCH 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: 21679250
• Report Number: 3015967359-2025-00552
• Device Sequence Number: 18077586
• Product Code: GEI
• UDI-Device Identifier: 07613327117202
• UDI-Public: (01)07613327117202(17)271025(10)2443017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0703047000
• Device Lot Number: 2443017
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown