MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP OPTABLATE 15 MM PROBE DUAL KIT; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	9700-015-200
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was treated with a bone tumor ablation using an optablate device.After the procedure, the patient was unable to move one of their legs.There was no allegation of a product malfunction.
Event or Problem Description
It was reported that the patient was treated with a bone tumor ablation using an optablate device.After the procedure, the patient was unable to move one of their legs.There was no allegation of a product malfunction.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.

• Brand Name: OPTABLATE 15 MM PROBE DUAL KIT
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• 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 ; 2693237700
• MDR Report Key: 21699898
• Report Number: 3015967359-2025-00569
• Device Sequence Number: 15431202
• Product Code: GEI
• UDI-Device Identifier: 07613327524512
• UDI-Public: (01)07613327524512(11)240409(17)260409(10)1000558416
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K221074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9700-015-200
• Device Lot Number: 1000558416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/24/2025
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown