Coblation AC2340-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817470000696), received between Feb 28, 2018 and May 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE SIDEWINDER BLADE ICW BROKE AFTER OPERATING THE DEVICE A FEW TIMES. THE BROKEN TIP DID NOT FELL INSIDE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086254 ↗
• MalfunctionJan 16, 2024Material Too Rigid or Stiff; Arcing of Electrodes; Material Deformation; Material Too Rigid or Stiff; Arcing of Electrodes; Material Deformation

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR, THE SIDEWINDER BLADE COULD NOT BEND. THERE WAS A BACK-UP DEVICE AVAILABLE AND A NON-SIGNIFICANT DELAY WAS REPORTED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION FOUND THAT THE BLACK SHRINK WRAP IS DEFORMED AND TORN AT THE DISTAL END AND SHOWS BARE METAL UNDERNEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519120 ↗
• MalfunctionJul 21, 2021Arcing; Protective Measures Problem; Arcing; Protective Measures Problem

  IT WAS REPORTED THAT THE QUANTUM2 DISPLAYED A HARDWIRE FAILURE ERROR SOON AFTER USING THE WAND IN AN ARTHROSCOPY. AFTER THE PROBLEM, A FUNCTIONALITY CHECK WAS DONE AND OCCURRED THAT A FLEXIBLE PART OF THE WAND OCCURRED AN ELECTRIC SPARK. THIS FAILURE MODE WAS CONFIRMED DURING FUNCTIONALLY CHECK FOR THE DEVICE IN THE AIR, NOT IN THE SALINE SOLUTION. NO PATIENT INJURY, DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207521 ↗
• MalfunctionNov 23, 2018Break

  IT WAS REPORTED THAT THE TIP DID NOT WORK. THERE WAS NOT DELAY AND NO PATIENT INJURIES. NO BACK-UP DEVICE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8099991 ↗
• MalfunctionFeb 28, 2018Device Alarm System; Break; Noise, Audible

  IT WAS REPORTED THAT DURING USE, A BREAKAGE SOUND WAS HEARD AND THE CONTROLLER ALARMED UNTIL THE WAND WAS DISCONNECTED. UPON INSPECTION OF THE WAND, IT WAS FOUND THAT THE SHEATH (INSULATION) WAS DAMAGED. ANOTHER WAND WAS OPENED TO COMPLETE THE CASE. NO PATIENT/USER INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304372 ↗