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	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.D4: lot number updated based on the additional information provided.
Event or Problem Description
It was reported that during a procedure the coag function on the e-sep pencil did not work but the cut function did.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during a procedure the coag function on the e-sep pencil did not work but the cut function did.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
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: 21056144
• Report Number: 3015967359-2025-00007
• Device Sequence Number: 15492266
• Product Code: GEI
• UDI-Device Identifier: 07613327117189
• UDI-Public: (01)07613327117189(17)270304(10)2410004
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/31/2025

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: 0703046000
• Device Lot Number: 2410004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/31/2025
• 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