Coblation AC4340-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00817470003314), received between Jan 5, 2018 and Oct 15, 2025 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, IT WAS NOTICED THAT WHITE PLASTIC FELL OFF FROM A COVATOR TIP. IT WAS SPLIT INTO TWO PIECES; ONE PIECE WAS RETRIEVED USING A GRASPER. ANOTHER PIECE WAS LEFT AT THE BOTTOM OF THE PATIENT¿S SHOULDER AS IT WAS TOO DIFFICULT TO REACH; THIS COULD RESULT IN WORN ON THE PATIENT¿S SHOULDER. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. PATIENT STATUS IS NORMAL, RECOVERING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23286520 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF THE METACARPOPHALANGEAL JOINT, WHEN THE CUSTOMER OPENED THE PACKAGE OF THE COVATOR AND STARTED USING IT, IMMEDIATELY UPON CONNECTING IT, A PIECE BROKE OFF FROM THE LIGHT-COLORED PART. THE DEVICE WAS NOT USED WITH EXCESSIVE FORCE; THE PIECE BROKE OFF DURING NORMAL USE. THE BROKEN PIECE WAS REMOVED USING RONGEURS. SURGERY WAS COMPLETED USING A S+N BACKUP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF 5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825102 ↗
• InjuryMar 22, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A CAPSULAR RELEASE SURGERY, A SMALL METAL PIECE PEEL OFF FROM THE TIP OF THE 'COVATOR 20' WAND. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACKUP DEVICE. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING OUTFLOW SUCTION. THE PATIENT WAS NORMAL AND DISCHARGED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847374 ↗
• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER STABILIZATION SURGERY, THE WHITE CASING ON THE TIP OF THE COVATOR WAND CAME APART AND FELL OFF INSIDE THE PATIENT. THE PIECE WAS REMOVED WITH GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS POST SURGERY RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974107 ↗
• InjuryMay 15, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY THE COVATOR WAND CHIPPED DURING USE, THE DEVICE BROKE INSIDE THE PATIENT AND THE BROKEN PIECE DID NOT REMAIN IN THE PATIENT IT WAS FLUSHED WITH PERFUSATE J. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10063693 ↗
• MalfunctionAug 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY, THE TIP BROKE OFF. AS PER REPORTER, NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT'S ANATOMY. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NEITHER SURGICAL DELAY NOR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932901 ↗
• MalfunctionAug 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE CERAMIC PART WAS DETACHED FROM THE TIP OF THE WAND. THE PIECE DID NOT REMAIN IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE, NO DELAY, NO PATIENT INJURY, THE AFFECTED WAND AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881539 ↗
• MalfunctionJul 2, 2019Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLACK END OF THE WANDS CRACKED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8755881 ↗
• MalfunctionJul 2, 2019Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLACK END OF THE WANDS CRACKED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8755811 ↗
• MalfunctionMay 14, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP WAS TORN. THERE ARE NO PARTS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8609859 ↗
• MalfunctionMay 14, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP WAS TORN. THERE ARE NO PARTS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609843 ↗
• MalfunctionMay 14, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP WAS TORN. THERE ARE NO PARTS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609821 ↗
• MalfunctionApr 10, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ASK PROCEDURE, THE DEVICE TIP WAS TORN DURING NORMAL USE. THERE ARE NO PARTS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500395 ↗
• MalfunctionApr 10, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ASK PROCEDURE, THE DEVICE TIP WAS TORN DURING NORMAL USE. THERE ARE NO PARTS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500338 ↗
• MalfunctionApr 10, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ASK PROCEDURE, THE DEVICE TIP WAS TORN DURING NORMAL USE. THERE ARE NO PARTS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500295 ↗
• MalfunctionJan 5, 2018No Display/Image; Melted

  IT WAS REPORTED THAT THE WAND WENT BLACK AND THE WHITE COLLAR MELTED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167438 ↗