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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cutting (cut) and coagulation buttons have been reversed.It was also reported that there were no adverse consequences and procedure was completed successfully.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: 24894965
• Report Number: 3015967359-2026-00238
• Device Sequence Number: 13071300
• Product Code: GEI
• UDI-Device Identifier: 07613327466331
• UDI-Public: (01)07613327466331(17)280926(10)2539026
• 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
• 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
• Device Catalogue Number: 0703046004
• Device Lot Number: 2539026
• 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: 08/05/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 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