Coblation AC4330-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00817470004854), received between Oct 17, 2017 and Jan 12, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE TIP OF A SABER 30 WAND ROTATED INSIDE THE PATIENT ON ITS FIRST USE, THEN BROKE OFF INSIDE THE PATIENT. THE DOCTOR WAS ABLE TO REMOVE IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036976 ↗
• MalfunctionAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE SABER 30 DEGREE ICW WAND DETACHED. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. 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 22829644 ↗
• InjuryFeb 6, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR INTERVAL RELEASE, A 7 MM CANNULA WAS INSERTED THROUGH THE ANTERIOR SUPERIOR PORTAL AS THE 5 MM CANNULA WOULD NOT FIT THE HOOK TIP RADIOFREQUENCY DEVICE. APPARENTLY, SMITH AND NEPHEW, THE MANUFACTURER OF THESE INSTRUMENTS HAD CHANGED THE HOOK TIP RADIOFREQUENCY DEVICE TO A CURVED INSTRUMENT WITH ABOUT A 10-DEGREE CURVE OR SO AND THIS REQUIRED A 7 MM CANNULA FOR ITS INSERTION. THE SURGEON INSERTED THE CANNULA AND THEN USING THE RADIOFREQUENCY TIP OPENED THE DENSE SCARRED ROTATOR INTERVAL DOWN TO THE LEVEL OF THE SUBSCAPULARIS. THIS NOTABLY IMPROVED EXTERNAL ROTATION TO AT LEAST 30 DEGREES. THE SURGEON THEN CONTINUED RELEASING WITH A RADIOFREQUENCY DEVICE THROUGH THE MIDDLE GLENOHUMERAL LIGAMENT AND THE INFERIOR GLENOHUMERAL LIGAMENT. THE SURGEON THEN REMOVED THE CANNULA AND INSERTED THE RADIOFREQUENCY DEVICE IN ORDER TO HAVE AN UNIMPEDED APPROACH TO THE ANTERIOR AND INFERIOR CAPSULE AND RELEASED THIS AS WELL DOWN TO ABOUT THE 5 O'CLOCK POSITION. UPON REMOVING THE HOOK TIP RADIOFREQUENCY DEVICE, IT WAS EVIDENT THAT THE TIP HAD BROKEN. THERE WAS NO EVIDENCE OF IT WITHIN THE JOINT. THE SURGEON VISUALIZED THROUGH NOT ONLY THE POSTERIOR

  Patient problems: Foreign Body In Patient

  MAUDE report 13467149 ↗
• MalfunctionNov 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, IT WAS NOTICED THAT A SMALL PORTION ON THE TIP OF A SABER 30 DEGREE WAS BROKEN. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879680 ↗
• InjuryNov 22, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT IN A SHOULDER ARTHROSCOPY, WHEN USING THE WAND, UNDER NORMAL CONDITIONS, THE METAL TIP OF THE WAND BROKE OFF IN THE TISSUE. THE DOCTOR LOOKED FOR THE BROKEN PIECE WITH THE SCOPE BUT COULD NOT FIND IT. AFTER THAT, AN X-RAY WAS TAKEN FOR DOCUMENTATION, AND THE PIECE WAS FOUND. THE DOCTOR DECIDED TO LEFT THE PIECE INSIDE THE PATIENT SINCE IT WAS TOO DIFFICULT TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12858722 ↗
• MalfunctionFeb 22, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, IN THE MIDDLE OF A KNEE SURGERY, THE "SABER 30° IC WAND" STOPPED WORKING AND SHOWED AN ERROR ON THE SCREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO SURGICAL DELAY, PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362339 ↗
• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE SABER COBLATION WAND BROKE OFF WHEN IT WAS BEING USED TO INCISE THE HIP CAPSULE AND ACCESS TO THE JOINT. THE BROKEN TIP COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10853327 ↗
• MalfunctionApr 2, 2020Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT DURING SURGERY, AFTER USING THE SABER WAND, A BURNING SMELL WAS PERCEIVED FROM IT. THE CONNECTION WAS CHECKED AND IT WAS EVIDENT THAT THE CONSOLE CONNECTOR WAS BLACK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE HELP OF AN ELECTRO SCALPEL. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 9919234 ↗
• MalfunctionSep 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE PIECE BENT IN THE JOINT AND AT THE TIME OF FIXING IT BROKE. THE EVENT OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A COMPETITOR BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109442 ↗
• MalfunctionApr 24, 2019Output Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE DEVICE DID NOT WORK. THE PROCEDURE HAD TO BE COMPLETED USING A COMPETITOR DEVICE, WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8545330 ↗
• MalfunctionMar 15, 2019Fracture; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE RADIO FREQUENCY SABER 30 WAS PASSED IN ORDER TO RELEASE TISSUE THROUGH THE CANNULA, BUT THIS PRESENTS RESISTANCE AND WHEN WE WERE TRYING TO INTRODUCE IT A FRACTURE SOUND WAS HEARD, IT WAS VERIFIED AND IT WAS EVIDENT THAT THE HOOK OF THE RADIOFREQUENCY DID NOT COME OUT. THE RESPECTIVE SEARCH WAS MADE INSIDE THE CANNULA AND THE PATIENT, BUT IT WAS NOT FOUND. THE PIECES WAS LEFT INSIDE THE PATIENT IN A PLACE WHERE IS NO DANGER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8425845 ↗
• MalfunctionJun 19, 2018Break

  IT WAS REPORTED THAT WHILE THE WAND WAS PASSING THROUGH A SKIN PORTAL DURING A KNEE ARTHROSCOPY THE TIP BROKE OFF THE SABRE 30 WAND. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616646 ↗
• MalfunctionMay 24, 2018Break; Positioning Problem

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY, IT WAS REQUIRED TO PERFORM A CAPSULOTOMY, A SABER 30 DEGREE ICW WAS NECESSARY, THE DEVICE WAS PASSED TO THE SURGICAL TABLE AND IT WAS INSERTED INTO THE PATIENT'S HIP, THE TIP BECAME ENTANGLED IN THE PATIENT TISSUE, AND WHEN TRIED TO REMOVE IT, THE TIP BROKE INSIDE THE PATIENT. BROKEN PIECE WAS REMOVED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO SIGNIFICANT SURGICAL DELAY OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540276 ↗
• MalfunctionDec 12, 2017Device Displays Incorrect Message

  IT WAS REPORTED THAT AFTER DEACTIVATION OF THE WAND THE MACHINES ERROR ALARM WENT OFF. I UNPLUGGED THE WAND AND THE ALARM STILL WENT OFF. I THE SWITCHED THE QUANTUM 2 OFF TO SILENCE THE MACHINE. A COMPETITOR WAND WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7107362 ↗
• MalfunctionOct 17, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE METAL HOOK OF THE SABER 30 WAND BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Information

  MAUDE report 6955821 ↗

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