Uniblate 700-103598Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H7877001035981), received between Dec 20, 2017 and Jan 6, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE TROCAR FALL APART DURING THE OPERATION. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554905 ↗
• InjuryOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: DURING AN RFA PROCEDURE USING AN UNIBLATE FRA PROBE, IT WAS REPORTED THE TROCAR DETACHED FROM THE PROBE. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. AS THE TREATMENT WAS NOT COMPLETED, THE PATIENT WAS SEDATED UNNECESSARILY. THIS IS CONSIDERED AN ADVERSE PATIENT EFFECT DUE TO PATIENT SAFETY RISK. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192643 ↗
• InjuryJul 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON JULY 03, 2018: DURING AN RFA PROCEDURE, THE TREATING PHYSICIAN USED A UNIBLATE 10CM RFA PROBE TO ABLATE A 1.3CM OSTEOID OSTEOMA OF THE LOWER LEFT TIBIA. HE PLANNED TO ABLATE THE SUPERIOR PORTION OF THE NIDUS/LESION FIRST AND THEN MOVE THE PROBE POSITION TO ABLATE THE INFERIOR PORTION OF THE NIDUS/LESION. THE RFA GENERATOR WAS SET FOR 5 MINUTES, AT 35 WATTS AND AT 90 C. AFTER WARMING UP AND REACHING TARGET TEMPERATURE THE PHYSICIAN NOTICED AT THE 2-MINUTE MARK WHAT APPEARED TO BE A SKIN BURN APPEARING AT THE INSERTION SITE AROUND THE UNIBLATE PROBE. HE STOPPED THE RFA GENERATOR AFTER 2 MINUTES OF DELIVERING THE ENERGY AND EXAMINED THE PATIENT. THE DOCTOR REMOVED THE UNIBLATE PROBE AND I (ANGIODYNAMICS' REPRESENTATIVE) NOTICED THAT THE EXPOSURE ON THE PROBE WAS SET AT 3CM. I RECOMMENDED THAT THE UNIBLATE PROBE EXPOSURE BE REDUCED AND SET AT 1CM TO REDUCE THE POSSIBILITY OF A SKIN BURN. THE DOCTOR THOUGHT THE EXPOSURE OF THE UNIBLATE PROBE WAS SET FOR 1CM OUT OF THE PACKAGE FROM ANGIODYNAMICS. HE REDUCED THE EXPOSURE OF THE PROBE TO 1CM, REINSERTED THE PROBE AND BEGAN TO ABLATE AT THE PREVIOUSLY SET TIME AND WATTAGE STATED ABOVE. AFTER COMPLETION OF THE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7734944 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON NOVEMBER 28, 2017: THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. PATIENT WAS HAVING RFA TO TREAT OSTEOID OSTEOMA IN THE LEFT DISTAL FEMUR. THE BURN WAS AT THE INSERTION SITE. THE DOCTOR AND CLINICAL SPECIALIST BOTH AGREE THAT THIS OCCURRENCE WAS A RESULT OF THE PLACEMENT OF THE CANNULA INTRODUCER LOCATION, CAUSING A "BACKFIRE" OF HEAT TO BURN THE TISSUE DUE TO THE SUPERFICIAL LOCATION, NOT AS A RESULT OF A MALFUNCTION OF THE DEVICE. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn(s)

  MAUDE report 7133260 ↗