MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	0703-046-004
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgical pencil was not working when activated, enter cannula detached off when surgeon attempted to adjust hand piece.

• Brand Name: STRYKER
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 23062010
• Report Number: 23062010
• Device Sequence Number: 9987329
• Product Code: GEI
• UDI-Device Identifier: 07613327466331
• UDI-Public: (01)07613327466331(17)280312(10)2511018
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2025
• Report Date (Section F): 09/08/2025

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 Model Number: 0703-046-004
• Device Catalogue Number: 0703-046-004
• Device Lot Number: 2511018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Date Report Sent to FDA: 09/08/2025