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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/24/2023
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 covidien tip did not work in the e-sep pencil, a reusable extender (not stryker) was insterted into the pen and a covidien tip was placed onto that.While this allowed the pen to work, the insulated section of this tip then burned the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.
Additional Manufacturer Narrative
F10/h6 correction: excessive heat.H6: the quality investigation is complete.H3 other text: device not returned.
Event or Problem Description
It was reported that during a procedure, when the covidien tip did not work in the e-sep pencil, a reusable extender (not stryker) was insterted into the pen and a covidien tip was placed onto that.While this allowed the pen to work, the insulated section of this tip then burned the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.

• 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: 18371840
• Report Number: 0001811755-2023-00245
• Device Sequence Number: 18037095
• Product Code: GEI
• UDI-Device Identifier: 37613327466332
• UDI-Public: 37613327466332
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 10/14/2024
• Device Catalogue Number: 0703046004
• Device Lot Number: 2142041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• 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