MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp OPTABLATE CURVE 15MM PROBE SINGLE KIT; Electrosurgical, cutting & coagulation & accessories

Catalog Number	9700-115-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the optablate probe broke after ablating while the doctor was removing it from the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Correction: d9; h3.The device was not returned for evaluation; therefore, a root cause could not be determined for the event.

• Brand Name: OPTABLATE CURVE 15MM PROBE SINGLE KIT
• Common Device Name: Electrosurgical, cutting & coagulation & accessories
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 24821578
• Report Number: 3015967359-2026-00216
• Device Sequence Number: 9601122
• Product Code: GEI
• UDI-Device Identifier: 07613327601152
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 9700-115-000
• Device Lot Number: 1000596842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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