OsteoCool™ RF Ablation System OC01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000167639), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THAT THE DEVICE HAD LOOSE CONNECTION. AT THE STAGE WHERE THE WATER HAS TO FLOW INTO THE PUMP, THERE WAS AN ERROR MESSAGE THAT POPS UP ASKING US TO CHECK THE CABLE CONNECTION, AND THEREAFTER IT WAS NOT ABLE TO PROCEED ON. THERE WAS NO KNOWN PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PRE-OP DIAGNOSIS: THORACIC METZ TUMOR, PROCEDURE INVOLVED: RF ABALATION/ KYPHOPLASTY. LEVELS IMPLANTED:1. PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT BECAUSE MACHINE WAS NOT ABLE TO BE START UP. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HCP SWITCHED THE PROCEDURE TO MICROWAVE PROCEDURE. THE GENERATOR WAS SHOWING ERROR MESSAGE. THERE WAS NO ALLEGATION AGAINST THE STAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892107 ↗