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

Model Number	9700120000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Probe emtter broke during procedure.

• Brand Name: OPTABLATE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 24604311
• Report Number: 24604311
• Device Sequence Number: 18756562
• Product Code: GEI
• UDI-Device Identifier: 07613327601145
• UDI-Public: (01)07613327601145(17)270820(10)1000610095
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/12/2026
• Report Date (Section F): 03/12/2026

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 Model Number: 9700120000
• Device Catalogue Number: 9700-120-000
• Device Lot Number: 1000610095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Date Report Sent to FDA: 03/12/2026