UltraClean 139112Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 40653405007235), received between Feb 17, 2022 and Mar 3, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Fragmentation; Melted

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 139112, ULTRACLEAN ACCESSORY ELECTRODE 4" (10.16 CM) COATED BLADE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿DURING A PROCEDURE WITH A LOT OF CAUTERY THE 4 INCH GUARDED TIP SECTION APPEARED TO MELT ENOUGH TO THE POINT WHERE THE GUARDED SECTION AND THE GREY STABILITY HOLDER CAME APART FROM THE ACTUAL BLADE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED AND FOUND THAT THERE WAS FRAGMENTATION THAT FELL INTO THE SURGICAL SITE. THE FRAGMENTATION WAS RETRIEVED USING FORCEPS. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494751 ↗
• MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037724 ↗
• InjuryJun 20, 2022Fracture; Fracture

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 139112, ULTRACLEAN 4 IN. BLADE 50/CASE WAS BEING USED ON (B)(6) 2022 DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION, POSTERIOR SPINAL INSTRUMENTATION FUSION, BILATERAL SACROILIAC JOINT FUSION, AND HARDWARE REMOVAL AND "WHEN USING PRODUCT SKU 139112 THERE WAS NO VISIBLE INDICATION OF ISSUE WITH DEVICE UPON OPENING AND USING AT BEGINNING OF CASE. SURGEON BENT THE ELECTRODE AND IT WAS AFTER THAT SURGEON REALIZED THE INSULATION BREACH WHERE INSULATION MEETS PLASTIC ON ELECTRODE. SURGICAL TEAM EXCHANGED FOR ANOTHER 139112 AND SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. STRAY BURN FROM INSULATION BREACH ON ELECTRODE. DRESSING APPLIED IN ORDERLY FASHION.¿ FURTHER ASSESSMENT FOUND THAT IT IS NOT BELIEVED THAT BENDING THE ELECTRODE CAUSED THE DEVICE TO BREAK. THE SURGEON HAS BEEN OPERATING AND USING THIS TECHNIQUE WITHOUT PREVIOUS ISSUE. PER SURGEON, ELECTRODE WAS USED WITH MINIMAL BENDING. THE BURN WAS ALONG THE INCISION, AND IT IS NOT KNOWN WHAT DEGREE OF BURN WAS RECEIVED. THE COVIDIEN FORCE FX ELECTROSURGICAL GENERATOR WAS USED AT 45 WATTS AND WILL BE LISTED AS A CONCOMITANT DEVICE. THERE WAS NO SIGNIFICANT DE

  Patient problems: Burn(s)

  MAUDE report 14742580 ↗
• MalfunctionMar 31, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969806 ↗
• MalfunctionMar 31, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138114A, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969770 ↗
• MalfunctionFeb 17, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139112, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548124 ↗