ULTRABLATOR ESA-5379Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854029589), received between Sep 29, 2017 and Jun 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2018Mechanical Problem; Mechanical Problem

  THIS DISTRIBUTOR REPORTED THAT THE ESA-5379, ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM DIAMETER, QTY 5, DEVICE WAS FOUND TO HAVE A HOLE IN THE DEVICE'S SHAFT COVER NEAR THE TIP DURING USE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2018. THE TYPE OF PROCEDURE BEING PERFORMED IS UNKNOWN, AS WELL AS IF THIS EVENT CAUSED A DELAY. IT WAS REPORTED; HOWEVER, THAT THE DEVICE COMPONENTS DID NOT REQUIRE RETRIEVAL AS NO COMPONENT OF THE DEVICE FELL INTO THE SURGICAL SITE. THE REPORTER STATED THAT THERE WAS NO INJURY TO THE PATIENT OR USER. AND THERE WAS NO EXTENDED STAY OF HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7610813 ↗
• MalfunctionSep 29, 2017Flaked; Flaked

  THE USER FACILITY REPORTED THAT AFTER TEN MINUTES OF USE OF THE ULTRABLATOR 90 DEGREE IN A SHOULDER ARTHROSCOPY, IT WAS NOTED THAT THE ELECTRODE TIP WAS DAMAGED AND A PORTION OF THE CERAMIC INSULATION WAS MISSING ON THE PROBE. NO PIECES OF THE PROBE FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH THE USE OF A BACKUP DEVICE. THE GENERATOR SETTING WAS SET TO CONSTANT CUT 100/COAG 100. THERE WAS NO PATIENT INJURY AND ONLY A SLIGHT DELAY OF APPROXIMATELY 5-MINUTE. THIS REPORT IS BEING FILED ON THE BASIS OF THE POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906564 ↗