OsteoCool™ RF Ablation System OCP215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169871625), received between Jul 13, 2019 and Jul 13, 2019 — classified as 1 injury.

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.

• InjuryJul 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING ABLATION FOLLOWED BY KYPHOPLASTY AT T10 AND T11 DUE TO METASTATIC TUMOR. INTRA-OP, PATIENT¿S BLOOD PRESSURE AND HEART RATE STARTED TO DROP IN THE MIDDLE OF SECOND LEVEL ABLATION (AFTER 1HOUR AND 20MINUTES INTO THE PROCEDURE). THE ANESTHESIA WAS REVERSED AND FLUIDS WERE GIVEN TO HER BUT BOTH PARAMETERS CONTINUED TO DROP; AND EVENTUALLY, THE PATIENT CODED AFTER SECOND LEVEL ABLATION WAS COMPLETED. RAPID RESPONSE TEAM WAS CALLED AND SHE WAS BROUGHT BACK AFTER HER HEART STOPPED. PATIENT WAS SENT TO THE ICU WITHOUT BALLOONING OR CEMENTING. PATIENT HAD CODED 2 DAYS PRIOR TO THE CASE, BUT WAS CLEARED BY CARDIOLOGY. BOTH LEVELS WERE ABLATED BUT NO BALLOONING OR CEMENTING HAVE BEEN DONE. ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENT WAS RELATED TO PATIENT'S MEDICAL CONDITION AND NOT PROCEDURAL RELATED. ON (B)(6) 2019, THE PATIENT WAS STILL IN ICU BUT AWAKE AND RESPONSIVE. NO ADDITIONAL SURGERY HAS BEEN SCHEDULED YET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED SINCE THE OPERATION.

  Patient problems: Diminished Pulse Pressure

  MAUDE report 8787393 ↗