ULTRABLATOR ESA-5396Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10845854020623), received between Jan 5, 2018 and Apr 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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.

• MalfunctionApr 25, 2022Material Puncture/Hole; Material Puncture/Hole

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, ESA-5396, ULTRABLATOR 90 DEGREE, 110MM LENGTH, 3.2MM DIAMETER WAS BEING USED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿IT WAS CONFIRMED THAT THE DEVICE HAD A HOLE IN THE TIP, SO THE CUSTOMER USED ANOTHER DEVICE. THE SURGERY WAS SUCCEEDED WITHOUT ANY PROBLEMS.¿ AN ALTERNATE DEVICE OF THE SAME WAS USED. FURTHER ASSESSMENT FOUND THAT ¿A FRAGMENT WAS NOT CONFIRMED¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193482 ↗
• MalfunctionNov 14, 2019Material Puncture/Hole; Material Puncture/Hole

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE ESA-5396 DEVICE WAS BEING USED DURING AN UNKNOWN SURGERY ON (B)(6) 2019 WHEN THE DEVICE GOT A HOLE IN THE SHAFT COVER NEAR THE TIP. IT WAS CONFIRMED THAT NO FRAGMENTATION FELL INTO THE PATIENT AND THERE WAS NO REPORT OF A DELAY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION DUE TO THE EVENT. 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 9320936 ↗
• MalfunctionMar 6, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER JOINT SURGERY, HOLES WERE OBSERVED ON TWO ESA-5396 ULTRABLATOR PROBES AT THE TIP OF THE SHAFT. THEREFORE, THE SURGEON USED AN ALTERNATIVE ONE TO COMPLETE THE SURGERY. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317160 ↗
• MalfunctionJan 5, 2018Charred; Charred

  A DISTRIBUTOR IN (B)(4) REPORTED ON BEHALF OF A USER FACILITY A "BOX DAMAGED" FOR THIS ESA-5396 ABLATOR ON (B)(6) 2017. UPON THE CONCLUSION OF THIS DEVICE EVALUATION, REPORTABILITY WAS REVISITED ON (B)(6) 2017. THE EVALUATION OF THE DEVICE FOUND THE TIP OF THIS ABLATOR TO BE CHARRED. IT WAS REPORTED THAT A SMALL HOLE WAS FOUND ON THE PRODUCTS' SHAFT COVER NEAR THE TIP DURING USE. THE FEMORAL CARTILAGE WAS OBSERVED TO BE BURNED AND THE SURGEON SPECULATED THIS WAS DUE TO LEAKAGE FROM THE HOLE. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATIVE DEVICE. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION IDENTIFIED DURING EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168843 ↗