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

Catalog Number	0703046002
Medical Device Problem Codes	Unintended Power Up (1162); Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a procedure when the e-sep pencil was plugged into the console the "cut" function activated.The pencil was unplugged and reconnected to the console.The same issue occurred.The pencil was removed from the field and a replacement pencil was used.It was also reported that this event did not occur during a surgical procedure, and there was no delay, medical intervention or adverse consequences as a result of this event.
Event or Problem Description
It was reported that during a procedure when the e-sep pencil was plugged into the console the "cut" function activated.The pencil was unplugged and reconnected to the console.The same issue occurred.The pencil was removed from the field and a replacement pencil was used.It was also reported that this event did not occur during a surgical procedure, and there was no delay, medical intervention or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: SMOKE EVAC. PENCIL COATED PB,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: 17663133
• Report Number: 0001811755-2023-00120
• Device Sequence Number: 6190407
• Product Code: GEI
• UDI-Device Identifier: 37613327379489
• UDI-Public: 37613327379489
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 03/19/2025
• Device Catalogue Number: 0703046002
• Device Lot Number: 62291709
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2022
• 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