UltraClean 139110EXT (UDI 40653405007341)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 40653405007341), received between May 25, 2016 and Jul 10, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE DEVICE, 139110EXT, ACCESSORY ELECTRODE COATED BLADE W/EXTENDED INSULATION WAS BEING USED ON (B)(6) 2025 AND ¿WHILE CAUTERIZING, THE DOCTOR EXPERIENCED A SPARK THROUGH THE DISTAL, INSULATED PORTION OF THE 6¿ COATED BLADE WITH EXTENDED INSULATION BOVIE TIP WHICH CAUSED A SUPERFICIAL THERMAL INJURY TO THE PATIENT.¿ THE PROCEDURE WAS COMPLETED WITH A MEGADINE BOVIE TIP AND THERE WAS A 2-HOUR DELAY. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. A GOOD FAITH EFFORT WAS COMPLETED TO OBTAIN MORE INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22469549 ↗
• InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE 139110EXT, ACCESSORY ELECTRODE COATED BLADE W/EXTENDED INSULATION DEVICE WAS USED IN AN UNNAMED PROCEDURE ON APPROXIMATELY ON (B)(6) 2025, AND "THIS BOVIE BURNT THE PATIENT UNDER DOCTORS USE." FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A BURN OF UNKNOWN DEGREE TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22174672 ↗
• MalfunctionMar 29, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139110EXT, 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 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 19003092 ↗
• MalfunctionMar 3, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139110EXT, 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 13658696 ↗
• MalfunctionFeb 28, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139110EXT, 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 13618640 ↗
• MalfunctionDec 6, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139110EXT, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. 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 12932892 ↗
• MalfunctionMay 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139110EXT, 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 11875669 ↗
• MalfunctionMay 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139110EXT, 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 11875645 ↗
• MalfunctionAug 18, 2020Material Separation

  SURGEON WAS USING THE BOVIE WITH THE EXTENDER TIP WHEN THE SHEATH CAME OFF OF THE EXTENDER TIP. HE THEN REMOVED THE OUTER SHEATH OF THE BOVIE EXTENDER ( REF#: (B)(4)) BECAUSE IT CAME OFF FROM THE MAIN SHAFT OF THE EXTENDER. IT WAS NOT LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10419772 ↗
• MalfunctionMay 17, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR IN (B)(4) REJECTED ONE 139110EXT, ULTRACLEAN ELECT: 6"BLDE EXT IN, DUE TO AN "INSUFFICIENT HEATSEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7522431 ↗
• MalfunctionMar 5, 2018Flare or Flash; Flare or Flash

  A CUSTOMER REPORTED DURING A BREAST IMPLANT EXCHANGE, THE (B)(4) TIP WAS USED WITH A VALLEY LAB ENERGY GENERATOR ON 30CUT 60COAG AND THE TIP FLASHED. THE SURGEON IMMEDIATELY REMOVED THE DEVICE FROM THE SURGICAL SITE AND VISUALLY INSPECTED IT FOR DAMAGE. HE DESCRIBED THE DAMAGE AS "CHARRED AT THE FLASH SITE". NO PATIENT OR USER INJURY WAS REPORTED AND THIS DEVICE MALFUNCTION DID NOT CAUSE A SURGICAL DELAY. 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 7314392 ↗
• MalfunctionJun 13, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED BY THE DISTRIBUTOR, DURING INCOMING INSPECTION IT WAS DETERMINED THE PACKAGING OF A (B)(4) EXT ULTRACLEAN 6" BLADE WAS DAMAGED AND STERILITY COULD BE COMPROMISED. THIS PRODUCT WAS REJECTED/NOT DISTRIBUTED AND RETURNED TO CONMED FOR EVALUATION. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 6638922 ↗
• MalfunctionMay 25, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, TWO (2) PACKAGES CONTAINING THE ULTRACLEAN 6" COATED BLADE WITH EXTENDED INSULATION WERE DISCOVERED WITH "INSUFFICIENT HEAT SEALS". BOTH OF THE RETURNED PACKAGES EXHIBITED CREASES IN THE FINAL MANUFACTURING SEALS. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALIES WERE DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5679093 ↗