MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp Smoke Evac. Pencil Coated PB,Non-Sterile; Electrosurgical cutting and coagulation device and accessories

Catalog Number	0703046002
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure at the user facility, the device tip caught fire.It was reported that the issue had no impact on the patient.It was further reported that there were no adverse consequences and no medical intervention as a result of this event.No information was provided regarding whether the procedure was completed successfully or whether the issue caused a surgical delay.
Additional Manufacturer Narrative
D4: lot number of the device is unknown - full udi is not available.

• Brand Name: Smoke Evac. Pencil Coated PB,Non-Sterile
• Common Device Name: Electrosurgical cutting and coagulation device and accessories
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Ireland; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; +353()214532900
• MDR Report Key: 50052912
• Report Number: 3015967359-2026-00450
• Device Sequence Number: 9608762
• Product Code: GEI
• UDI-Device Identifier: 07613327379488
• UDI-Public: (01)07613327379488
• 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
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 0703046002
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/28/2026
• 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