Coblation ASH4830-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00817470004908), received between May 5, 2017 and Jun 28, 2026 — classified as 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K083306); 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2026Degraded

  IT WAS REPORTED THAT, DURING A SYNOVECTOMY PROCEDURE, A SUPER MULTIVAC 50 TIP DISINTEGRATED AND THE WAND STOPPED WORKING. THE QUANTUM BOX DID NOT ALERT, AND THE SETTINGS WERE SET TO 9 AND 2. A C-ARM WAS TAKEN OUT TO MAKE SURE THERE WAS NOT ANY METAL LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A 30 MINUTE DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. THE PATIENT EXPERIENCED POST OPERATIVE SEVERE PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25648523 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, THE METAL ELECTRODE AT THE FRONT END OF ONE (1) SUPER MULTIVAC FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED USING A COMPETITOR DEVICE. IT IS UNCERTAIN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512532 ↗
• InjuryMar 17, 2026Material Separation

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE TIP OF THE SUPER MULTIVAC 50 HAD FALLEN OFF. IT WAS UNCLEAR WHETHER THE TIP HAD FALLEN INTO THE JOINT CAVITY OR OUTSIDE THE BODY. AFTER WOUND CLOSURE, IMAGING WAS PERFORMED USING A C-ARM, WHICH REVEALED THREE SMALL BLACK SPOTS. THE PRESENCE OF THE DETACHED TIP INSIDE THE PATIENT COULD NOT BE RULED OUT. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE, IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24619792 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE METAL AT THE FRONT END OF THE SUPER MULTIVAC WAND CAME OFF. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710678 ↗
• MalfunctionMay 8, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE SUPER MULTIVAC 50 IFS WAND STERILE PACKAGING WAS NOT SEALED COMPLETELY. IT IS UNKNOWN WHETHER THE EVENT OCCURRED DURING SURGERY, AND THERE WAS NO CONFIRMATION OF PATIENT INVOLVEMENT OR A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984742 ↗
• MalfunctionFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCOPLASTY PROCEDURE, HALF OF THE SUPER MULTIVAC WAND'S ELECTRODE FELL OFF INSIDE THE PATIENT AND WAS REMOVED WITH SUCTION. THE SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE, AFTER A SIGNIFICANT SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319541 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE ELECTRODE ON THE SUPER MULTIVAC 50 FELL OFF AFTER THE WAND WAS INTRODUCED INTO THE ARTICULAR CAVITY. THE ELECTRODE WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20580167 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TERMINAL TIP OF THE MULTIVAC 50 WAND DETACHED INSIDE THE PATIENT JOINT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145536 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUPER MULTIVAC WAND WAS INSERTED INTO THE HIP JOINT AND IMMEDIATELY AFTER ACTIVATION, THE PLATE FELL OFF. THE TILE HAS BEEN COMPLETELY REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607955 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PLATE OF ONE SUPER MULTIVAC WAND LOOSENED AT THE TIP OF THE ELECTRODE AND FELL OFF. THE PLATE WAS REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607754 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PLATE OF A SUPER MULTIVAC WAND LOOSENED AT THE TIP OF THE ELECTRODE AND FELL OFF. THE PLATE WAS REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607747 ↗
• MalfunctionJul 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE METAL PLATE OF THE SUPER MULTIVAC WAND DETACHED FROM THE ELECTRODE. THE METAL PLATE WAS REMOVED FROM THE PATIENT USING GRASPING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376001 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE METAL PLATE ON THE SUPER MULTIVAC ELECTRODE CAME LOOSE AND FELL INTO THE PATIENT'S WOUND. ALL THE PIECES WERE REMOVED WITH GRASPING FORCEPS. 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 17260255 ↗
• MalfunctionApr 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE SCOPE, IT WAS DISCOVERED THAT TWO SEPARATE PIECES FROM THE METAL TIP OF THE SUPER MULTIVAC WAND CAME OFF THE DEVICE. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVED BOTH PIECES FROM THE PATIENT'S JOINT SPACE. THE PROCEDURE WAS COMPLETED WITH A 30-MINUTE DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792747 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 DAYS AFTER A KNEE ARTHROSCOPY WITH A COBLATION PROBE PARAGON T2 AND A COBLATION PROBE SUPERMULTIVAC 50, A PATIENT RETURNED TO THE OPERATING ROOM TO CLEAN BLISTERS ON THE SKIN. THE PROBES WERE USED IN THE MEDIAL PORTAL OF THE RIGHT KNEE AND THE BLISTERS WERE FORMED IN THE LATERAL PORTAL, ALL THE WAY DOWN THE LEG. A SMITH & NEPHEW SKIN CARE DRESSING FOR WOUND CARE WAS USED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14418623 ↗
• MalfunctionSep 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SUPERMULTIVAC WAS NOT FUNCTIONING PROPERLY, THE METAL TIP PROBABLY BURNED OFF (OVERHEATED) BECAUSE IT CAME OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493574 ↗
• InjurySep 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING SHOULDER SCOPE, THE METAL TIP OF THE SUPER MULTIVAC 50 IFS BURNED OFF AND WAS FALLING OFF INSIDE THE PATIENT. TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474306 ↗
• MalfunctionMar 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE SUPER MULTIVAC 50 WAS FOUND TO BE BROKEN. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THE WAND'S FLAT-SCREEN ELECTRODE IS DETACHED AND NOT AVAILABLE WHICH INDICATES AN ACTUAL FRAGMENTATION OF THE DEVICE AND THIS MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9841821 ↗
• MalfunctionOct 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE METAL PART AT THE END OF THE ELECTRODE DETACHED. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9160374 ↗
• MalfunctionSep 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A RIGHT HIP ARTHROSCOPY PROCEDURE, A METAL PART AT THE END OF THE ELECTRODE DETACHED WHILE INSERTED INTO THE PATIENT. THE TIP HAS BEEN FOUND AND WAS RECOVERED. THE PROCEDURE WAS EXTENDED BY 1 HOUR AND 30 MINUTES AND NO REPORT OF PROCEDURE CANCELLATIONS WERE RECEIVED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9134473 ↗
• MalfunctionAug 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY IT WAS DISCOVERED THE DEVICE'S TIP HAD FELL INSIDE THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY WAS REPORTED. NO INJURY WAS REPORTED; HOWEVER, THE TIP REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8878351 ↗
• MalfunctionAug 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF THE RIGHT HIP, THE METAL PART OF THE TIP OF THE WAND CAME OFF AS THE WAND WAS IN THE PATIENT. THE SURGEON RESEARCHED THE PIECE BUT THE PIECE HAS NOT BEEN FOUND BACK. NO FURTHER ACTION HAS BEEN UNDERTAKEN FOR THE MOMENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8866493 ↗
• InjuryDec 11, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING KNEE SCOPE, THE FACE/ELECTRODE OF THE WAND CAME OFF IN THE JOINT. ALL PIECES WERE REMOVED. THERE WAS NOT DELAY IN THE CASE AND BACK UP DEVICE WAS AVAILABLE. NOT PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151375 ↗
• MalfunctionJul 23, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SURGERY THE METAL PART OF THE SUPER MULTIVAC 50 ELECTRODE DETACHED ITS SELF FROM THE TOP. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711153 ↗
• MalfunctionApr 19, 2018Detachment Of Device Component; Component Falling

  IT WAS REPORTED THAT THE FACE PLATE FELL INTO THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO MAJOR DELAY OR PATIENT INJURIES. IT IS UNKNOWN IF PLATE WAS REMOVED FROM PATIENT AS NO INFORMATION HAS BEEN RECEIVED FROM REPORTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443891 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083306. One submission often covers many models, so check the product and lot details in each record.

• Z-0579-2015 · Oct 27, 2014 · Terminated
  Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are ind