MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMOKE TELE PENCIL COATED PB; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703046004
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
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 surgical procedure, while using the e-sep pencil, the patients tissue around the cutting area gets very hot.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.This is event #1 of 2.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, while using the e-sep pencil, the patients tissue around the cutting area gets very hot.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.This is event #1 of 2.

• Brand Name: SMOKE TELE PENCIL COATED PB
• 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: 17949079
• Report Number: 0001811755-2023-00162
• Device Sequence Number: 12680137
• Product Code: GEI
• UDI-Device Identifier: 37613327466332
• UDI-Public: 37613327466332
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K182354
• 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): 01/08/2024

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: 03/23/2026
• Device Catalogue Number: 0703046004
• Device Lot Number: 2313010
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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