Coblation ASC4251-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00817470001716), received between Oct 18, 2017 and Jul 13, 2025 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE OF THE BALLS AT THE ELECTRODE TIP OF THE STARVAC 90 ICW HAD COME LOOSE. THERE WAS NOTHING LEFT IN PATIENT¿S JOINT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 22491226 ↗
• MalfunctionMay 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BLACK ALLOY OF THE STARVAC 90 WAND ELECTRODE CAME OFF IN THE JOINT WHEN IT WAS RELEASED; THE DETACHED PARTICLES WERE SUCKED IN DIRECTLY AND DID NOT REMAIN IN THE JOINT. THE ELECTRODE WAS TRIGGERED FOR APPROX. 2-3 MINUTES WITHOUT INTERRUPTION IN THE JOINT UNDER NACL. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19245695 ↗
• MalfunctionOct 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SET UP, THE STARVAC 90¿S TIP DETACHED. THERE WAS A S+N BACK UP DEVICE AVAILABLE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970084 ↗
• MalfunctionJun 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SET UP FOR SURGERY, THE SUCTION TIP OF THE STARVAC WAND SEPARATED AND FELL OFF. NONE OF THE PIECES FELL INTO THE PATIENT. ALL PIECES WERE RETRIEVED BY THE DOCTOR. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND A NON SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227717 ↗
• MalfunctionApr 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE WITH RCR, IT WAS NOTICED THAT ONE OF THE VERY SMALL METAL BALLS FROM THE STARVAC WAND'S TIP WAS MISSING. THE SURGEON WAS ABLE TO FIND IT QUICKLY, AND REMOVED IT FROM THE PATIENT WITH A GRASPER. A BACKUP DEVICE WAS AVAILABLE, BUT IT WAS NOT USED TO COMPLETE THE PROCEDURE WITHOUT DELAY, SINCE THE PROBLEM WAS NOTICED AFTER THE SURGEON WAS DONE WITH THE DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792904 ↗
• InjuryOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, AN ELECTRODE OF THE STARVAC 90° WAND DETACHED AND REMAINED IN PLACE AT THE PATIENT'S HIP. THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 15658842 ↗
• InjuryNov 24, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN THE STARVAC WAND WAS INTRODUCE INSIDE THE PATIENT, THE METAL PLATE AT THE TIP FELL OFF. IT WAS LOCALIZED WITH THE BV (X-RAYS) AND ASPIRATED VIA THE SHAVER. ALL PIECES WERE SUCCESSFULLY REMOVED ROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS GOOD. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868147 ↗
• MalfunctionOct 7, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKING SEAL OF THE STARVAC 90 ICW PACKAGED WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594325 ↗
• InjurySep 20, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THE TIP ELECTRODE OF THE STARVAC 90 ICW GOT BROKEN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502145 ↗
• InjurySep 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING SHOULDER ARTHROSCOPY, AN ELECTRODE OF A STARVAC 90 ICW WAS SEPARATED AND FELL OFF. IRRIGATION WAS PERFORMED TO REMOVE THE BALL, BUT IT WAS DIFFICULT TO CONFIRM WITH THE NAKED EYE, AND THE OPERATION WAS COMPLETED WITH THE SAME DEVICE. A DELAY OF LESS OR EQUAL TO 30MIN WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432061 ↗
• MalfunctionJul 13, 2021Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE STARVAC WAND BLACK INSULATION ON THE SHAFT CHARRED AND CAME LOOSE. THE DEVICE STILL HAVE BLISTERING ON THE DISTAL SHAFT DUE TO OVERHEATING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160481 ↗
• MalfunctionJul 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP FOR A SHOULDER ARTHROSCOPY, TOWARDS THE TIP OF THE WAND WERE TWO METAL/PLASTIC PIECES AND DOCTOR WAS WORRIED THESE COULD BE LET INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124777 ↗
• MalfunctionNov 27, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE STARVAC WAND HAD AN E4 ERROR CODE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10913926 ↗
• MalfunctionSep 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PLASTIC ON THE SHAFT HAS DISSOLVED AFTER ONE MINUTE OF USE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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 Information

  MAUDE report 10515774 ↗
• MalfunctionJun 5, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THE STARVAC SHOWED AN ERROR E4 WHEN CONNECTED. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10124563 ↗
• InjuryApr 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE STARVAC ELECTRODE WAS DECOMPOSED AND FELL OFF. IT IS UNKNOWN IF THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY GREATER THAN 30 MINUTES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10015957 ↗
• MalfunctionFeb 4, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, DEVICE WAS NOT GETTING AN ENERGY OUTPUT, DEVICE DID NOT PRESENT ANY ERROR CODE OR AUDIBLE ALARM. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR DEVICE. NO DELAY OR PATIENT INJURIES 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 9664157 ↗
• InjuryNov 13, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DEVICE WAS BEING USED AND LOOKED LIKE A "FLAME THROWER", LIKE A RED GLOWING PROBE WITH INTENSE HEAT DEVELOPMENT AT INTENSITY OF MAGNITUDE 7. THERE WAS A 10 MINUTES DELAY BUT OPERATION WAS FINALLY COMPLETED AND REMAINING MATERIAL OF THE JOINT THAT HAD TO BE REMOVED WAS REMOVED WITH A MILLING CUTTER. PATIENT SUFFERED A SHOULDER SECOND DEGREE BURN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY

  Patient problems: Burn(s)

  MAUDE report 9314749 ↗
• InjuryNov 13, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DEVICE WAS BEING USED AND LOOKED LIKE A "FLAME THROWER", LIKE A RED GLOWING PROBE WITH INTENSE HEAT DEVELOPMENT AT INTENSITY OF MAGNITUDE 7. THERE WAS A 10 MINUTES DELAY BUT OPERATION WAS FINALLY COMPLETED AND REMAINING MATERIAL OF THE JOINT THAT HAD TO BE REMOVED WAS REMOVED WITH A MILLING CUTTER. PATIENT SUFFERED A SHOULDER SECOND DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 9314712 ↗
• MalfunctionOct 9, 2019Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, AFTER CONNECTING THE WAND, THE STARVAC 90 ICW WAND DID NOT WORK; IT WAS TRIED BOTH ABLATION AND COAGULATION MODES. THE SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9173449 ↗
• InjuryJul 31, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE BACK OF THE DEVICE'S TIP OVERHEATED. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY WAS REPORTED. AN INJURY TO THE CONDYLE (IMPRINT ON NON-WEIGHT BEARING PART) WAS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 8848519 ↗
• InjuryJul 31, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE OVERHEATED CAUSING THE PLASTIC SHEATHING TO MELT. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH THE SAME DEVICE. NO DELAY WAS REPORTED. AN INJURY WAS REPORTED ON THE CONDYLE (TWO IMPRINTS ON NON-WEIGHT BEARING PART).

  Patient problems: Burn(s)

  MAUDE report 8848516 ↗
• MalfunctionMay 30, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE, THE DEVICE HAD A POSSIBLY OVERHEATING ISSUE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8656558 ↗
• MalfunctionJan 8, 2019Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE HEAD WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227748 ↗
• MalfunctionOct 28, 2018Material Separation

  IT WAS REPORTED THAT THE PLATE OF HEAD PART FELL OUT WHEN IT WAS USED FIRST TIME AFTER OPENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8011674 ↗