Coblation EIC5874-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00817470004595), received between Sep 12, 2017 and Jun 3, 2026 — classified as 35 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Arcing” (28 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 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Leak/Splash; Connection Problem

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE HANDLE CONNECTION OF AN EVAC 70 XTRA WAND WAS LEAKING AND THE HEAD OF THE WAND WAS SPINNING. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25380825 ↗
• InjuryJun 1, 2026Activation Failure

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE EVAC 70 XTRA HP COBLATOR II WAND SUDDENLY STOPPED CUTTING. IT WAS IMPOSSIBLE TO STOP THE BLEEDING EITHER. AFTER REPEATED ATTEMPTS WITHOUT SUCCESS, THE SURGERY WAS COMPLETED USING A BIPOLAR ELECTROCOAGULATION TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY; THE DURATION OF THE DELAY IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25354535 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE METAL WIRE OF AN EVAC 70 XTRA WAND FRACTURED OUTSIDE OF THE PATIENT WHEN IT WAS USED FOR 10 MINUTES. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345327 ↗
• MalfunctionMay 11, 2026Intermittent Energy Output

  IT WAS REPORTED THAT, DURING A TAR SURGERY, ONE (1) EVAC 70 COBLATOR WAND WAS UNABLE TO FORM THE PLASMA ON THE TIP INTERMITTENTLY. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145401 ↗
• MalfunctionFeb 20, 2026Failure to Deliver Energy; Suction Problem

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, ONE (1) EVAC 70 WAND COULD NOT CUT THE TISSUE AND IT WAS CLOGGED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP, THERE WAS A DELAY GREATER THAN 30 MIN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402192 ↗
• MalfunctionFeb 20, 2026Arcing

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, ONE (1) EVAC 70 WAND WAS SPARKING. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP, WITH A DELAY GREATER THAN 30 MIN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401870 ↗
• MalfunctionFeb 17, 2026Overheating of Device; Arcing; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE, THE EVAC 70 WAND EMITTED SPARKS AND WAS OVERHEATING. THE PROCEDURE WAS RESUMED AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364471 ↗
• MalfunctionJan 12, 2026Break; Melted

  IT WAS REPORTED THAT, DURING AN ADENOID HYPERTROPHY RESECTION SURGERY, THE ELECTRODE WIRE OF AN EVAC 70 XTRA HP COBLATOR II WAS MELTED AND FRACTURED, MAKING IT IMPOSSIBLE TO PROCEED. NO PIECES FELL INTO THE PATIENT. 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 24045275 ↗
• MalfunctionDec 15, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT, DURING SURGERY, AN EVAC 70 XTRA WAND SMOKED AND OVERHEATED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803451 ↗
• MalfunctionNov 19, 2025Degraded; Suction Problem; Degraded; Suction Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY & TONSILECTOMY, FIVE (5) EVAC 70 XTRA HP COBLATOR II WAND TIPS WERE DEGRADING TOO QUICKLY , HAD POOR SUCTION CAPABILITY AND EXPERIENCED FREQUENT BLOCKAGE. THE PROCEDURE WAS RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH AN EQUIVALENT SN DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596674 ↗
• MalfunctionNov 18, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING A TONSILLECTOMY WITH ADENOID HYPERTROPHY PROCEDURE, THE EVAC 70 XTRA HP COBLATOR II EMITTED WHITE SMOKE ABNORMALLY, AFTER ADJUSTING THE SUCTION OF THE DEVICE AND COOLING WITH PHYSIOLOGICAL SALINE, NO RESULTS WERE ACHIEVED. THERE WAS OVERHEATING OF THE WAND BECAUSE OF THE ISSUE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586066 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, USING THE EVAC WAND, THE PATIENT SUFFERED INTRAOPERATIVE BLEEDING, THE BLEEDING COULD NOT BE STOPPED AND THERE WAS POSTOPERATIVE BLEEDING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23430013 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, USING THE EVAC WAND, THE PATIENT SUFFERED INTRAOPERATIVE BLEEDING, THE BLEEDING COULD NOT BE STOPPED AND THERE WAS POSTOPERATIVE BLEEDING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23429880 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, USING AN EVAC 70 XTRA HP COBLATOR II WAND, THE PATIENT SUFFERED INTRAOPERATIVE BLEEDING, THE BLEEDING COULD NOT BE STOPPED AND THERE WAS POSTOPERATIVE BLEEDING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23426371 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, USING THE EVAC WAND, THE PATIENT SUFFERED INTRAOPERATIVE BLEEDING, THE BLEEDING COULD NOT BE STOPPED AND THERE WAS POSTOPERATIVE BLEEDING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23425536 ↗
• MalfunctionSep 28, 2025Overheating of Device; Smoking; Activation Failure; Overheating of Device; Smoking; Activation Failure

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE EVAC 70 XTRA SMOKED, COULD NOT CUT TISSUE AND OVERHEATED. THE ENT PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164077 ↗
• MalfunctionSep 28, 2025Overheating of Device; Smoking; Activation Failure; Overheating of Device; Smoking; Activation Failure

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE TISSUE COULD NOT BE CUT WHILE USING THE EVAC 70 XTRA. THE WAND SMOKED AND OVERHEAT. THE ENT PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164076 ↗
• MalfunctionSep 17, 2025Flaked; Material Integrity Problem; Flaked; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SINUS SURGERY, AN UNIDENTIFIED SUBSTANCE HAS APPEARED ON THE BACK OF THE EVAC 70 WAND TIP AS A RESULT OF THE ABLATION PROCESS, AND CHIPS OF THE SUBSTANCE FELL OFF. ALL CHIPS WERE REMOVED FROM THE PATIENT USING SUCTION AND IRRIGATION. THE UNIDENTIFIED MATERIAL VISUALLY RESEMBLED MOLTEN PLASTIC. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075291 ↗
• MalfunctionSep 17, 2025Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, AN UNKNOWN SUBSTANCE GRADUALLY APPEARED ON THE WHITE COATING ON THE BACK OF THE EVAC 70 XTRA HP COBLATOR II DURING THE ABLATION PROCESS. THE UNIDENTIFIED SUBSTANCE VISUALLY RESEMBLED MOLTEN PLASTIC. THE PIECES WERE REMOVED FROM THE PATIENT BY WASH AND SUCTION. THE SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE, A NANOS MEDICAL. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073235 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A NASAL MASS FESS AND SEPTOPLASTY PROCEDURE WHERE AN UNKNOWN COBLATION DEVICE WAS USED, THE PATIENT GOT INFECTED WITH CLIVAL BONE OSTEOMYELITIS. IT IS UNKNOWN HOW WAS THE PATIENT TREATED, AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Osteomyelitis

  MAUDE report 23063612 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY TWO OR THREE WEEKS AFTER A NASAL MASS FESS AND SEPTOPLASTY PROCEDURE WHERE AN EVAC 70 XTRA HP COBLATOR II WAS USED, THE PATIENT GOT INFECTED WITH CLIVAL BONE OSTEOMYELITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER COMPLICATIONS REPORTED, PATIENT'S HEALTH STATUS IS GOOD.

  Patient problems: Osteomyelitis

  MAUDE report 23063561 ↗
• MalfunctionSep 12, 2025Failure to Deliver Energy; Material Deformation; Unexpected Shutdown; Failure to Deliver Energy; Material Deformation; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE, TWO (2) EVAC 70 WANDS EXPERIENCE ELECTRODE BURNOUT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043795 ↗
• MalfunctionSep 2, 2025Overheating of Device; Smoking; Suction Problem; Overheating of Device; Smoking; Suction Problem

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE EVAC WAND WAS CLOGGED, SMOKING AND OVERHEATING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932487 ↗
• MalfunctionSep 2, 2025Overheating of Device; Smoking; Suction Problem; Overheating of Device; Smoking; Suction Problem

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE EVAC WAND WAS CLOGGED, MAKING IT DIFFICULT TO CUT, AND IT WAS OVERHEATING AND SMOKING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932399 ↗
• MalfunctionJul 28, 2025Melted; Melted

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE EVAC 70 WAND DAMAGED, THE ELECTRODE WAS MELTED. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628578 ↗