UltraClean 139105EXT (UDI 40653405033258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 40653405033258), received between Feb 13, 2018 and Sep 18, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 23082570 ↗
• InjuryApr 30, 2025Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE 139105EXT, ACCESSORY ELECTRODE COATED NEEDLE WAS BEING USED ON (B)(6) 2025 DURING A RESECTION OF HEAD TUMOR PROCEDURE WHEN IT WAS REPORTED ¿A PHYSICIAN WAS USING A 139105EXT AND CLOSED THE WOUND ON A PATIENT WITHOUT NOTICING THAT THE TIP WAS BROKEN. AFTER CLOSING THE WOUND, HE DISCOVERED THAT THE TIP OF THE PRODUCT WAS BROKEN. AFTER THE SURGERY, AN X-RAY WAS PERFORMED, BUT THE TIP COULD NOT BE FOUND. THE SURGERY WAS COMPLETED WITHOUT FINDING IT, AND THE PATIENT WAS INFORMED THAT THERE WAS A POSSIBILITY THAT THE PRODUCT WAS LEFT BEHIND.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO THE POSSIBILITY OF THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21933479 ↗
• MalfunctionDec 27, 2024Material Fragmentation; Sparking; Material Fragmentation; Sparking

  THE CUSTOMER REPORTED THAT THE 139105EXT, ACCESSORY ELECTRODE COATED NEEDLE WITH EXTENDED INSULATION, DEVICE WAS BEING USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE ELECTRODE STARTED SPARKING AND THEN THE PLASTIC COVERING FELL OFF SPLITTING INSIDE THE PATIENT.". FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED BUT TO DATE NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. UPDATE: THE CUSTOMER CONFIRMED THAT THIS EVENT OCCURRED DURING A BREAST PROCEDURE AND THE FRAGMENT WAS RETRIEVED FROM THE PATIENT BY HAND. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025687 ↗
• MalfunctionDec 26, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE 139105EXT, ACCESSORY ELECTRODE COATED NEEDLE WITH EXTENDED INSULATION, DEVICE WAS BEING USED IN AN UNKNOWN PROCEDURE ON (B)(6)2024 WHEN IT WAS REPORTED, ¿THE BLUE PLASTIC COVER COMPLETELY CAME OFF IN THE PATIENT AND THE SHARP PART FELL OFF INSIDE THE PATIENT WHICH WAS DIFFICULT TO RETRIEVE AND COULD HAVE CAUSED SOME HARM.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 21019028 ↗
• MalfunctionSep 6, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 20155641 ↗
• MalfunctionJul 31, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 139105EXT, ULTRCLN 1 IN. NEDL W/EXTND INSULATION WAS BEING USED ON (B)(6) 2024 DURING A PEDIATRIC NEUROLOGY PROCEDURE WHEN IT WAS REPORTED ¿INSULATION FELL OFF OF THE NEEDLE TIP.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FALL INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF FORCEPS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. 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 19871870 ↗
• MalfunctionDec 21, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371001 ↗
• MalfunctionApr 10, 2023Fire; Fire

  CONMED CANADA REPORTED ON BEHALF OF THE CUSTOMER THAT THE 139105EXT, ULTRCLN 1 IN. NEDL W/EXTND INSULATION WAS BEING USED DURING A TONSILS AND ADENOIDS PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿ONCE STARTED USING THE CAUTERY, TIP LIT ON FIRE, AND FIRE HAD TO BE EXTINGUISHED. SECOND TIP OPENED AND NO ISSUE (UNSURE IF IT WAS CAUTERY OR THE TIP)." FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID NOT MAKE PATIENT CONTACT AT THE TIME OF THIS INCIDENT AND ¿WE SWITCHED TO A NEW CAUTERY SET UP AND COMPLETED THE CASE¿. IT WAS CONFIRMED THAT THE PATIENT WAS NOT DIAGNOSED WITH A BURN. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 16708496 ↗
• MalfunctionJan 30, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 16267876 ↗
• MalfunctionJun 23, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 14788968 ↗
• MalfunctionJun 22, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 14771611 ↗
• MalfunctionMay 20, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 11856800 ↗
• MalfunctionMay 20, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 11856394 ↗
• MalfunctionMay 20, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139105EXT, 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 11856393 ↗
• MalfunctionApr 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, ULTRACLEAN 1IN NEEDLE ELECTRODE WITH EXTENDED INSULATION, CATALOG # 139105EXT, LOT 201910025, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(4) . THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717179 ↗
• MalfunctionJun 9, 2020Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE DEVICE, 139105EXT, WAS BEING USED DURING A PROCEDURE TO REMOVE A LUMP FROM THE PATIENT LEFT BREAST WHEN CUTTING WITH THE DEVICE "THE BLUE PROTECTIVE COVER SPLAYED OPEN NEAR THE NEEDLE END." THERE WAS NO FRAGMENTATION OF THE DEVICE OR ANY COMPONENTS AND THERE WAS NO REPORT OF DELAY. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE AS PLANNED. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION CAUSED BY 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 10132648 ↗
• MalfunctionSep 19, 2018Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT 139105EXT DEVICE TIP MELTED UPON ACTIVATION AND A SECOND DEVICE HAD THE SAME RESULTS DURING A HERNIA REPAIR PROCEDURE ON (B)(6) 2018. THE DEVICE WAS IN USE AT THE TIME OF EVENT; HOWEVER, NO COMPONENTS MET THE PATIENT OR SURGICAL SITE; THEREFORE, NO COMPONENTS OR FRAGMENTS REQUIRED REMOVAL. THE PATIENT DID NOT REQUIRE ANY TYPE OF MEDICAL INTERVENTION. ALSO, THERE WAS NO EXTENDED HOSPITAL STAY. THE PATIENT WAS REPORTED AS HAVING NO INJURY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURENCE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7890312 ↗
• MalfunctionFeb 23, 2018Fire; Fire

  A CUSTOMER REPORTED TO (B)(6), THEIR DISTRIBUTOR FOR ITEM 139105EXT ULTRACLEAN ELEXTRODE, THAT THE BOVIE TIP ASSOCIATED WITH MDR 3003705485-2018-00026 CAUSED A FLASH FIRE DURING USE. NO PATIENT INJURY WAS REPORTED. THESE TWO 139105EXT DEVICES WERE RETURNED UNUSED TO (B)(6) FOR TESTING, HOWEVER, A PHOTOGRAPH OF THE TIP "CHARRED" WAS PROVIDED. THIS REPORT IS RAISED ON THE BASIS OF A PHOTOGRAPH REVEALING A DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293882 ↗
• MalfunctionFeb 13, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(6) REPORTED A "SCRATCH" ON THE STERILE POUCH OF TWO ELECTRODE DEVICES. THERE WAS NO PATIENT INVOLVEMENT AS THESE DEFECTS WERE DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7268113 ↗