COBLATION EICA5872-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00817470003710), received between Jan 31, 2018 and Jun 2, 2026 — classified as 25 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT, DURING A BILATERAL TONSILLECTOMY, AN EVAC 70 XTRA WAS NOT WORKING PROPERLY; WHEN THE SPECIALIST TOOK THE DEVICE OUT TO LOOK AT IT, IT WAS NOTICED THAT THE 3 WIRE STRANDS ON THE HANDPIECE WERE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368665 ↗
• MalfunctionApr 29, 2026Break; Melted

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE OF THE EVAC 70 WAND MELTED AND FRACTURE AFTER 8-10 MINUTES OF USE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037279 ↗
• MalfunctionApr 29, 2026Break; Melted

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE ELECTRODE OF THE EVAC 70 WAND MELTED AND FRACTURE AFTER 8-10 MINUTES OF USE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037139 ↗
• MalfunctionApr 22, 2026Fracture

  IT WAS REPORTED THAT DURING A NASOPHARYNGEAL CARCINOMA PROCEDURE, THE TIP OF THE ELECTRODE OF THE EVAC COBLATOR WAND WAS FRACTURED AFTER 3 MINUTES OF USE. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958222 ↗
• InjuryNov 27, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A TONSILLECTOMY WITH ADENOIDECTOMY SURGERY, THE EVAC 70 WAND EXHIBITED AN INSULATION DEFECT ON THE LONG PART OF THE WAND, AND WHEN PRESSURE WAS APPLIED TO THE CORNER OF THE PATIENT¿S MOUTH, IT RESULTED IN A BURN ON THE CORNER OF THE MOUTH. THE BURN WAS NOTICED AFTER THE PROCEDURE WAS COMPLETED. VASELINE WAS APPLIED ON THE PATIENT BURN. A POSTOPERATIVE LIP COMMISSURE WAS DONE ON THE PATIENT. A COMPLETE HEALING OF THE BURN WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 23665910 ↗
• InjuryApr 11, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, IN WHICH AN EVAC 70 XTRA COBLATOR II WAS USED, A BLANCH BURN WAS DISCOVERED ON THE UPPER CORNER OF THE PATIENT'S LIP. THE SURGEON DID NOT FEEL THAT THE WAND WAS FULLY CONNECTED WITH THE METAL RETRACTOR, IT WAS NOTED THAT SALINE SOLUTION WAS LEAKING FROM THE CONNECTION, THIS MAY HAVE CAUSED THE TIP TO NOT RECEIVE ENOUGH SALINE SOLUTION. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH A DELAY OF THREE (3) MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED, THE PATIENT DID NOT REQUIRE A PROLONGED HOSPITALIZATION.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 21826612 ↗
• MalfunctionFeb 20, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE EVAC 70 WAND PACKAGE ARRIVED DAMAGED, WITH A HOLE IN THE OUTER SHIPPING CARDBOARD BOX. THE ACTUAL ITEM WAS DAMAGED AS WELL. THE ITEM'S BOX WAS CRUSHED ON ONE END AND HAD A HOLE IN IT. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421926 ↗
• MalfunctionJul 31, 2024Arcing; Arcing

  IT WAS REPORTED THAT, DURING A TONSIL AND ADENOID PROCEDURE, THE EVAC WAND WAS SPARKING OFF THE TIP OF THE WAND. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19873754 ↗
• MalfunctionMar 20, 2024Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY WITH ADENOIDECTOMY PROCEDURE, THE ELECTRODES OF THE EVAC 70 XTRA COBLATOR II BROKE DURING USE. NO FURTHER INFORMATION AVAILABLE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942192 ↗
• MalfunctionFeb 15, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A T&A PROCEDURE, THE MIDDLE ELECTRODE DETACHED FROM THE TIP OF THE EVAC 70 COBLATOR II. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY OF 1 MINUTE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712828 ↗
• MalfunctionJan 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TONSIL & ADENOID PROCEDURE, METAL PIECES CAME OFF THE EVAC WAND. THE PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509825 ↗
• MalfunctionJan 10, 2024Break; Arcing; Break; Arcing

  IT WAS REPORTED THAT DURING A T&A PROCEDURE, THE EVAC 70 XTRA WEAS SPARKING AND THEN QUIT WORKING. ALSO, THE SPECIALIST NOTED THAT THE ELECTRODE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 1-MIN DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486305 ↗
• MalfunctionJan 10, 2024Break; Arcing; Break; Arcing

  IT WAS REPORTED THAT DURING A T&A PROCEDURE, TWO (2) EVAC 70 XTRA WERE SPARKING AND THEN QUIT WORKING. ALSO, THE SPECIALIST NOTED THAT THE ELECTRODE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 1-MIN DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486210 ↗
• MalfunctionNov 21, 2023Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT DURING A TONSIL AND ADENOID PROCEDURE, THE TOP TWO PIECES OF THE EVAC 70 WAND BROKE OFF AND FELL INTO THE PATIENT'S THROAT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND IT IS UNKNOWN IF THE PIECES WERE REMOVED. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18186118 ↗
• MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY ON A PATIENTS TONSILS AND ADENOIDS, THE EVAC 70 XTRA COBLATOR WAND STOPPED ABLATING AND THE TIP OF THE ELECTRODE WAS MISSING. THE BROKEN PIECE WAS NOT LOCATED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333555 ↗
• MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY ON A PATIENTS TONSILS AND ADENOIDS, THE EVAC 70 XTRA COBLATOR WAND STOPPED ABLATING AND THE TIP OF THE ELECTRODE WAS MISSING. THE BROKEN PIECE WAS NOT LOCATED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333506 ↗
• MalfunctionJun 13, 2023Degraded; Smoking; Arcing; Degraded; Smoking; Arcing

  IT WAS REPORTED THAT AFTER SURGERY, WHEN HITTING THE ABLATE PEDAL, THE EVAC COBLATION WAND WAS GIVING OFF STEAM OR SMOKE AND IT WAS SPARKLING. ADDITIONALLY, IT WAS NOTICED THE DISTAL TIP HAD ELECTRODE WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117934 ↗
• MalfunctionJun 6, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE EVAC 70 XTRA BEGAN TO GET CLOGGED AND CHARRED AT THE END, THE STAFF ATTEMPTED TO CLEAN THE CHAR OFF WHEN IT BEGAN TO SPARK. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071045 ↗
• InjuryJun 5, 2023Suction Problem; Suction Problem

  IT WAS REPORTED THAT, DURING POSTERIOR MIDLINE GLOSSECTOMY, WHEN USING THE EVAC XTRA COBLATOR II, THE SURGEON HAD DIFFICULTY CONTROLLING THE BLEEDING BECAUSE THE COBLATOR WAS GETTING CLOGGED. SURGERY WAS COMPLETED WITH A SUCTION CAUTERY FROM MEDTRONIC (COMPETITOR DEVICE) WHICH HELPED STOP THE BLEEDING, HOWEVER, THE PATIENT HAD TO REMAINED INTUBATED OVERNIGHT. THE DELAY IS IS UNKNOWN AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17061955 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PERFORMED WITH AN EVAC 70 COBLATOR II WAND, A PATIENT PRESENTED A SECONDARY TONSIL REBLEED. THE PATIENT RETURNED TO THE OPERATING ROOM TO RESOLVE THE BLEEDING, BUT IT IS UNKNOWN WHAT REMEDIAL ACTIONS WERE TAKEN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17051953 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PERFORMED WITH AN EVAC 70 COBLATOR II WAND, A PATIENT PRESENTED A SECONDARY TONSIL REBLEED. THE PATIENT RETURNED TO THE OPERATING ROOM TO RESOLVE THE BLEEDING, BUT IT IS UNKNOWN WHAT REMEDIAL ACTIONS WERE TAKEN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17051917 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PERFORMED WITH AN EVAC 70 COBLATOR II WAND, A PATIENT PRESENTED A SECONDARY TONSIL REBLEED. THE PATIENT RETURNED TO THE OPERATING ROOM TO RESOLVE THE BLEEDING, BUT IT IS UNKNOWN WHAT REMEDIAL ACTIONS WERE TAKEN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17051790 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PERFORMED WITH AN EVAC 70 COBLATOR II WAND, A PATIENT PRESENTED A SECONDARY TONSIL REBLEED. THE PATIENT RETURNED TO THE OPERATING ROOM FOR REVISION. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17051719 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PERFORMED WITH AN EVAC 70 COBLATOR II WAND, A PATIENT PRESENTED A SECONDARY TONSIL REBLEED. THE PATIENT RETURNED TO THE OPERATING ROOM FOR REVISION. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17051710 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PERFORMED WITH AN EVAC 70 COBLATOR II WAND, A PATIENT PRESENTED A SECONDARY TONSIL REBLEED. THE PATIENT RETURNED TO THE OPERATING ROOM FOR REVISION. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17051697 ↗