Coblation ASHA4730-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00817470000436), received between Mar 19, 2018 and Jul 10, 2023 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, A PIECE OF THE AMBIENT HIPVAC BLACK SHEATH DETACHED FROM THE END OF THE ELECTRODE AND FELL INTO THE PATIENT. THE DETACHED PIECE WAS RECOVERED, BUT THE INCIDENT LENGTHENED THE OPERATING TIME. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288070 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO PIECES OF THE WAND ELECTRODE BROKE OFF INTO THE JOINT. BOTH PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH AN ARTHROSCOPIC GRASPER. THE ARTHROSCOPY WAS COMPLETED WITH NON SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861908 ↗
• InjuryFeb 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, A PIECE OF THE AMBIENT HIPVAC WAND BROKE OFF INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13623814 ↗
• InjuryOct 10, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE BLACK INSULATION ON THE SHAFT OF THE AMBIENT HIPVAC 50 IFS WAS CHIPPING OFF PARTS. SOME OF THOSE BLACK PARTS WERE IN THE JOINT AND WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12603009 ↗
• InjuryOct 7, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, AN AMBIENT HIPVAC 50 WAND WAS USED AND A PIECE OF THE HEAT SHRINK TUBING BECAME DETACHED AND FELL INTO THE PATIENT. THE DETACHED PIECE WAS RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A MULTIVAC XL WAND. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594825 ↗
• InjuryOct 7, 2021Break; Break

  IT WAS REPORTED THAT DURING A PSOAS TENOTOMY ON HIP PROSTHESIS THE AMBIENT HIPVAC 50 IFS ELECTRODE CAME OFF THE HANDLE INTO THE PATIENT. IT WAS A PIECE OF ABOUT 0.5 CM COMPLETE WHITE PART + ELECTRODE. THE DEVICE BROKE INSIDE THE PATIENT IT WAS RETRIEVED USING SUCTION. THE DURATION OF THE PROCEDURE WAS EXTENDED (UNKNOWN HOW MUCH). THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594762 ↗
• MalfunctionMay 5, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A SMALL PIECE OF THE BLACK PLASTIC COATING DETACHED ITSELF FROM THE DISTAL TIP OF THE WAND. THE PIECE WAS REMOVED/RECOVERED SAFELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW 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 11780984 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE METAL PLATE ON THE AMBIENT HIPVAC 50 IFS ELECTRODE CAME OFF. THE METAL PIECE WAS COMPLETELY REMOVED FROM WITHIN THE PATIENT AND THE PATIENT'S HEALTH STATUS IS GOOD. THE MALFUNCTION WAS SOLVED WITH NO SIGNIFICANT DELAYS USING A BACK UP DEVICE. NO FURTHER 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 11267914 ↗
• MalfunctionDec 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE METAL PLATE OF THE WAND FELL OFF IN THE PATIENT'S SOFT TISSUE AND COULD NOT BE RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11032951 ↗
• MalfunctionOct 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SET UP OF AN ARTHROSCOPY PROCEDURE, THE INSULATION OF THE AMBIENT HIPVAC 50 WAS PEELED OFF. THERE WAS NO DELAY AND A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10623773 ↗
• MalfunctionOct 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SET UP OF AN ARTHROSCOPY PROCEDURE, THE INSULATION OF THE AMBIENT HIPVAC 50 WAS DEFECTIVE. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 Patient Involvement

  MAUDE report 10623763 ↗
• MalfunctionJun 10, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING A HIP SURGERY, THE "AMBIENT HIPVAC 50° IFS WAND" STOPPED WORKING AND CREATING PLASMA WHILE DEBRIDING THE LABRUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10139862 ↗
• MalfunctionApr 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY A SMALL RING OF WHITE PLASTIC HAD BECOME DETACHED FROM THE TIP OF THE WAND. THE LOOSE PLASTIC PART WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY USING A CANNULA (SUCTIONED). NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 9919342 ↗
• MalfunctionFeb 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A HIP PROCEDURE, PART OF THE AMBIENT HIP VAC'S METAL TIP BECAME DETACHED FROM THE SHAFT. THE PIECE WAS SUCCESSFULLY RETRIEVED FROM THE HIP. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS 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 9706991 ↗
• MalfunctionNov 5, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY AFTER A FEW MINUTES OF USE, THE ELECTRODE OF THE HIPVAC 50 BROKE OFF AND FELL OFF INSIDE THE PATIENT'S JOINT. THE SURGEON REMOVED THE ELECTRODE USING A GRASPER. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 9281872 ↗
• MalfunctionJul 2, 2019Crack; Crack

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHILE THE WAND WAS BEING USED THE END OF THE WAND CRACKED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8755849 ↗
• MalfunctionApr 3, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ASK HIP SURGERY, THE ELECTRODE HEAD DETACHED FROM THE ELECTRODE DURING ABLATION INSIDE THE PATIENT, USING FORCEPS, THE PIECE WAS REMOVED. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476693 ↗
• MalfunctionMar 20, 2019Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING SURGERY, A PIECE OF PLASTIC FROM THE TIP OF THE DEVICE FELL OFF. IT WAS FOUND BEFORE THE WOUND COULD BE CLOSED. THE PIECE WAS FOUND AND REMOVED AND THE WOUND WAS CLOSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CONSIDERABLE DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438261 ↗
• MalfunctionMar 20, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ELECTRODE AT THE TIP OF THE WAND FELL OFF DURING HIP ARTHROSCOPY LABRAL REPAIR. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PART BY USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8437669 ↗
• MalfunctionFeb 14, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROTECTIVE RING OF HEAD WAS DETACHED FROM SHAFT DURING ABLATION. IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8341378 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SURGERY THE ELECTRODE HEAD DETACHED FROM THE ELECTRODE DURING ABLATION INSIDE THE PATIENT, WITH THE ASK FORCEPS EVERYTHING WAS REMOVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ANOTHER SMITH & NEPHEW DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332800 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE PROTECTIVE RING DETACHED FROM THE ELECTRODE HEAD AND FLOATED FREELY IN THE JOINT. EVERYTHING WAS LATER REMOVED WITH THE ASK FORCEPS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332047 ↗
• MalfunctionFeb 8, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE ELECTRODE HEAD DETACHED DURING ABLATION, THE PIECES WERE REMOVED WITH ASK FORCEPS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319734 ↗
• MalfunctionFeb 8, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE ELECTRODE HEAD DETACHED DURING ABLATION. EVERYTHING WAS LATER REMOVED WITH THE ASK FORCEPS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319630 ↗
• MalfunctionJan 31, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PROCEDURE AN ABLATION ELECTRODE HEAD LOOSENED. THE PIECE WAS REMOVED WITH GRASPING FORCEPS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293295 ↗