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	Unintended Power Up (1162)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the e-sep pencil activated without pushing the button to activate it.The area where the surgeon was using the pencil resulted in a cut that was unintended.This caused the incision to be jagged.The surgeon was able to rectify the area that was cut unintentionally when closing the incision.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.
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 pushing the button to activate it.The area where the surgeon was using the pencil resulted in a cut that was unintended.This caused the incision to be jagged.The surgeon was able to rectify the area that was cut unintentionally when closing the incision.The procedure was completed successfully without a clinically significant delay; no medical intervention was 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: 19351155
• Report Number: 3015967359-2024-01066
• Device Sequence Number: 12615738
• Product Code: GEI
• UDI-Device Identifier: 07613327177350
• UDI-Public: (01)07613327177350(17)250708(10)63842620
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Expiration Date: 07/08/2025
• Device Catalogue Number: 0703046000
• Device Lot Number: 63842620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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