MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMOKE EVAC. PENCIL COATED RS,NON-STERILE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703047002
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, when the e-sep pencil was connected to the console, it made a "beeping" noise.When the surgeon touched the pencil, she was burned.The item was replaced by another cautery device.The procedure was completed successfully without a delay.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation device is available for return.
Additional Manufacturer Narrative
Correction: this supplemental is being filed to identify that it is a duplicate report.The device in question was originally reported via mfr report #0001811755-2023-00125.
Event or Problem Description
It was reported that during a procedure, when the e-sep pencil was connected to the console, it made a "beeping" noise.When the surgeon touched the pencil, she was burned.The item was replaced by another cautery device.The procedure was completed successfully without a 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18380174
• Report Number: 0001811755-2023-00247
• Device Sequence Number: 15381695
• Product Code: GEI
• UDI-Device Identifier: 37613327379472
• UDI-Public: 37613327379472
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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 Catalogue Number: 0703047002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/30/2024
• 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