MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp SMOKE TELE PENCIL COATED PB; Electrosurgical cutting and coagulation device and accessories

Catalog Number	0703046004
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number of the device is unknown - full udi is not available.
Event or Problem Description
It was reported that the cutting (cut) and coagulation buttons have been reversed.No further information available at this time.

• Brand Name: SMOKE TELE PENCIL COATED PB
• 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: 24894959
• Report Number: 3015967359-2026-00237
• Device Sequence Number: 9239100
• Product Code: GEI
• UDI-Device Identifier: 07613327466331
• UDI-Public: (01)07613327466331
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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: 0703046004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 06/10/2026; 08/05/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/10/2026; 08/06/2026
• 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