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

Model Number	9700015200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure while positioning the probe under fluoroscopy the tip of the probe was noted to be broken off but nothing was left behind in the patient.A new probe was used to complete the procedure without medical intervention, delay, or adverse consequences to the patient.
Event or Problem Description
It was reported that during a procedure while positioning the probe under fluoroscopy the tip of the probe was noted to be broken off but nothing was left behind in the patient.A new probe was used to complete the procedure without medical intervention, delay, or adverse consequences to the patient.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17059994
• Report Number: 3015967359-2023-01228
• Device Sequence Number: 15597730
• Product Code: GEI
• UDI-Device Identifier: 07613327524512
• UDI-Public: 07613327524512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2023

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: 9700015200
• Device Catalogue Number: 9700-015-200
• Device Lot Number: 1000511085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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