Coblation ASC4830-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00817470003550), received between Jan 8, 2018 and Jun 3, 2026 — classified as 69 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Material Separation” (50 reports).

1 other recall cover devices cleared under the same FDA submission (K033584); they may or may not involve this specific model.

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 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Degraded; Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT, DURING A SURGERY, THE ELECTRODE TIP OF THE SUPER MULTIVAC CHARRED AND SHORT-CIRCUITED, CAUSING INTERMITTENT FUNCTION AND SEVERELY IMPACTING INTRAOPERATIVE USE. IT CAUSE OVERHEATING OF THE DEVICE. THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386268 ↗
• MalfunctionJun 1, 2026Degraded; Overheating of Device; Electrical Shorting; Intermittent Loss of Power

  IT WAS REPORTED THAT, DURING A SURGERY, THE ELECTRODE TIP OF THE SUPER MULTIVAC CHARRED AND SHORT-CIRCUITED, CAUSING INTERMITTENT FUNCTION AND SEVERELY IMPACTING INTRAOPERATIVE USE. IT CAUSE OVERHEATING OF THE DEVICE. THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356488 ↗
• MalfunctionMay 26, 2026Break; Degraded

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ELECTRODE TIP OF THE SUPER MULTIVAC WAND BECAME BURNT, AND FRAGMENTS WERE OBSERVED TO DETACH FROM THE ELECTRODE TIP. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279642 ↗
• MalfunctionMay 5, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, A SUPER MULTIVAC WAND HAD AN ELECTRODE ABLATION SITUATION. THE PROCEDURE WAS RESUMED, AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082928 ↗
• MalfunctionApr 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER REPAIR, THE ELECTRODE HEAD OF ONE (1) SUPER MULTIVAC WAND FELL OFF. NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919932 ↗
• InjuryApr 6, 2026Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPIC LABRAL REPAIR, THE END OF THE SUPER MULTIVAC 50 WAND FELL OFF INSIDE THE PATIENT. AN X-RAY WAS PERFORMED TO SEARCH FOR THE END OF THE WAND, AND THE FRAGMENT WAS FOUND IN THE JOINT CAVITY. THE LOCATION OF THE FRAGMENT WAS DEEP AND COULD NOT BE RETRIEVED AFTER AN HOUR AND A HALF OF SEARCHING, WHICH RESULTED IN DAMAGE TO THE PATIENT¿S BODY TISSUE AND MUCOSA. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING THE SAME DEVICE. THE PATIENT IS REPORTED TO BE IN FINE CONDITION; HOWEVER, THE ADVERSE EVENT RESULTED IN A PROLONGED HOSPITALIZATION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24788592 ↗
• MalfunctionApr 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PROCEDURE, IT WAS DISCOVERED THAT THE METAL PIECE AT THE TIP OF THE SUPER MULTIVAC WAND HAD DISAPPEARED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787082 ↗
• MalfunctionApr 5, 2026Component Missing

  IT WAS REPORTED THAT, DURING A SURGERY, UPON OPENING, THE METAL TIP COMPONENT AT THE DISTAL END OF ONE (1) SUPER MULTIVAC 50 WAS MISSING. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING A COMPETITOR DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786770 ↗
• MalfunctionMar 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARCR PROCEDURE, THE TIP ELECTRODE OF A SUPER MULTIVAC 50 ICW FELL OFF INSIDE THE PATIENT. AFTER X-RAYS, THE TIP ELECTRODE WAS NOT FOUND WITHIN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654869 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A KNEE LIGAMENT RECONSTRUCTION PROCEDURE, THE MULTIVAC WAND'S HEAD BECAME DETACHED AND WAS REMOVED USING GRASPERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344083 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, IT WAS NOTICED THAT THE SUPER MULTIVAC 50 ICW WAND'S ELECTRODE DETACHED. THE ELECTRODE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324729 ↗
• MalfunctionFeb 12, 2026Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A SUPER MULTIVAC WAND HAD A SHORT CIRCUIT AND WAS SCORCHING. 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 24321782 ↗
• MalfunctionJan 19, 2026Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR AND ACROMIOPLASTY, AFTER THE SURGERY WAS FINISHED, THE NURSE FOUND A MISSING METAL PIECE ON ONE (1) SUPER MULTIVAC WAND, WITH A SIZE OF ABOUT 2MM* 3MM. THE JOINT CAVITY WAS SEARCHED BUT THE METAL PIECE WAS NOT FOUND AFTER ABOUT 1 HOUR OF EXPLORATION. THE PATIENT'S STATUS IS FINE. THE PROCEDURE WAS RESUMED, AFTER ONE HOUR, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111893 ↗
• MalfunctionJan 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER JOINT REPAIR AND CLEANING SURGERY, THE TIP OF A SUPER MULTIVAC WAND FELL OFF INSIDE THE PATIENT AND WAS REMOVED USING FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111883 ↗
• MalfunctionJan 19, 2026Material Separation

  IT WAS REPORTED THAT, DURING A PARTIAL RESECTION OF MEDIAL MENISCUS, A SMALL FOREIGN OBJECT WAS FOUND IN THE SURGICAL FIELD. THE OPERATION WAS IMMEDIATELY STOPPED, AND THE SURGICAL INSTRUMENTS AND CONSUMABLES USED WERE INSPECTED. IT WAS DISCOVERED THAT THE FRONT METAL PART OF THE SUPER MULTIVAC 50 ICW WAS MISSING. AN IN-SITU SEARCH WAS CONDUCTED, AND THE MISSING METAL PART WAS FOUND IN THE SURGICAL FIELD AND REMOVED PROMPTLY. AN X-RAY WAS TAKEN SHOWING THAT THERE WERE NO FOREIGN OBJECTS IN 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 24111873 ↗
• InjuryDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROPLASTY, THE TIP ELECTRODE OF THE SUPER MULTIVAC 50 WAND DETACHED AND FELL INSIDE THE PATIENT; THE ELECTRODE WAS NOT RETRIEVED FROM WITHIN THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23917398 ↗
• MalfunctionDec 16, 2025Failure to Deliver Energy; Detachment of Device or Device Component; Failure to Deliver Energy; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUPER MULTIVAC WAND STOPPED WORKING, IT DID NOT GENERATE PLASMA, AND THE TIP ELECTRODE WAS BROKEN. IT IS UNKNOWN WHETHER THE PIECE WAS RETRIEVED FROM THE BODY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817171 ↗
• MalfunctionDec 16, 2025Degraded; Overheating of Device; Detachment of Device or Device Component; Degraded; Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A SUPER MULTIVAC WAND'S ELECTRODE HEAD SUFFERED FROM BURNING AND THE METAL ELECTRODE FELL OFF, WHICH SERIOUSLY AFFECTED THE USE DURING THE OPERATION. AFTER CAREFUL SEARCH UNDER THE JOINT MICROSCOPE FOR MULTIPLE TIMES, ALL THE FRAGMENTS WERE FINALLY REMOVED BY SUCTION. NO DAMAGE OR BURN WAS CAUSED DUE TO THE OVERHEATING OF THE DEVICE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816525 ↗
• InjuryNov 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE HEAD OF THE SUPER MULTIVAC 50 FELL INTO THE JOINT SPACE. THE ELECTRODE WAS NOT REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23450434 ↗
• MalfunctionOct 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE, THE METAL PART OF THE SUPER MULTIVAC DETACHED AND FELL INTO THE JOINT CAVITY. THE SURGEON IMMEDIATELY REMOVED THE METAL FRAGMENTS AND FLUSHED THE JOINT EXTENSIVELY WITH PHYSIOLOGICAL SALINE TO COMPLETE THE PROCEDURE. THE SURGERY WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263120 ↗
• InjurySep 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, IT WAS NOTICED THAT THE FACE PLATE OF THE SUPER MULTIVAC WAND HAD DETACHED AND REMAINED INSIDE THE PATIENT, IT WAS UNABLE TO BE RETRIEVED BY THE SURGEON. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23179881 ↗
• MalfunctionSep 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE METAL ELECTRODE AT THE FRONT END OF THE SUPER MULTIVAC 50 ICW FELL INTO THE JOINT CAVITY WHEN USING THE PLASMA KNIFE HEAD FOR ABLATION. THE RESIDUE WAS REMOVED BY COMBINING THE SUCTION TUBE AND FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048114 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP JOINT LABRUM REPAIR SURGERY, THE ELECTRODE HEAD OF THE SUPER MULTIVAC 50 ICW FELL OFF WHEN IT WAS USED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926217 ↗
• InjuryAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A BILATERAL ARTHROSCOPIC GLUTEAL MUSCLE CONTRACTURE RELEASE PROCEDURE, THE MULTIVAC WAND HAD PARTIALLY DETACHED, AN IMMEDIATE SEARCH WAS CARRIED OUT AND AFTER CB FLOUROSCOPY IT WAS DISCOVERED THAT THERE WAS RESIDUAL IN THE INCISION, AFTER EVALUATING THE RISK OF REMOVAL, THE DOCTOR DECIDED NOT TO REMOVE IT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22846359 ↗
• InjuryAug 7, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC GLUTEAL MUSCLE CONTRACTURE SURGERY, THE HEAD OF THE SUPER MULTIVAC FELL OFF. THE PIECE WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22737934 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033584. One submission often covers many models, so check the product and lot details in each record.

• Z-2309-2008 · Apr 9, 2008 · Terminated
  ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation access