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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during an orthopaedic procedure, the surgeon used the e-sep pencil to create a temporary bipolar device.The surgeon brought it off the field shortly after doing this, and considered it charred.It was also reported that there was a two minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned, photograph provided.
Event or Problem Description
It was reported that during an orthopaedic procedure, the surgeon used the e-sep pencil to create a temporary bipolar device.The surgeon brought it off the field shortly after doing this, and considered it charred.It was also reported that there was a two minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15259701
• Report Number: 0001811755-2022-00033
• Device Sequence Number: 5811291
• Product Code: GEI
• UDI-Device Identifier: 37613327466332
• UDI-Public: 37613327466332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182354
• 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): 10/24/2022

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: 0703046004
• Device Lot Number: 2003021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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