AMBIENT 72290004Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556614686), received between Jun 23, 2019 and Mar 14, 2026 — classified as 3 injuries, 16 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2026Material Separation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AN AMBIENT HIPVAC 50 IFS BROKE WHILE IN USE INSIDE OF THE PATIENT. THE PART OF THE BLACK RUBBER THAT WRAPS AROUND THE SHAFT OF THE WAND, DETACHED FROM THE SHAFT OF THE WAND AFTER INSERTING IT INTO THE PATIENT'S HIP. THE PIECE WAS REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A 10-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600275 ↗
• MalfunctionFeb 11, 2026Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE BLACK POLYMER COATING OF AN AMBIENT HIPVAC WAND STARTED TO SHEAR AWAY. AFTER VISUAL INSPECTION, THE FRAGMENTS WERE REMOVED FROM 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 24313678 ↗
• MalfunctionNov 24, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, ONE (1) AMBIENT HIPVAC WAND WAS NOT FUNCTIONING EFFICIENTLY. THE PLASTIC COATING BEGAN TO DETACH, PROBABLY DUE TO EXCESSIVE WEAR IN THE TIGHT JOINT SPACE. ALL THE DETACHED PLASTIC FRAGMENTS WERE FLUSHED AWAY USING THE SHAVER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 23639378 ↗
• MalfunctionAug 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A SMALL PIECE OF THE AMBIENT WAND ABLATION SHEATH, CAME OFF INSIDE THE PATIENT'S HIP CAPSULE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472507 ↗
• MalfunctionApr 3, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP OF AN ARTHROSCOPY PROCEDURE, WHEN THE BLISTER OF THE AMBIENT HIPVAC DEVICE WAS TAKEN OUT OF THE BOX, THE PACKAGING HAD A HOLE. HOWEVER, THERE WAS NO SIGN OF TAMPERING ON THE CARDBOARD PACKAGE CONTAINING IT. THE PROCEDURE WAS DELAYED FOR 5 MINUTES. BACK-UP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665727 ↗
• InjuryMar 14, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A PART OF THE BLACK PLASTIC INSULATION OF THE AMBIENT BROKE AWAY. THE PIECES WERE REMOVED BY GRASPER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756824 ↗
• InjuryJul 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN UNPACKING THE AMBIENT HIPVAC 50 IFS OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE STERILE PLASTIC PACKAGING WAS DEFECTIVE. A BACKUP DEVICE WAS AVAILABLE TO CONTINUE WITH THE PROCEDURE WITH NO DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213744 ↗
• InjuryMay 17, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THE AMBIENT HIPVAC STARTED TO INTERFERE WITH THE MONITOR BY TURNING IT OFF. AFTER THE CABLES WERE DISCONNECTED AND THE SOCKET WAS SWITCHED, IT STARTED TO SHOW AN ERROR E7. IT WAS SWITCHED TO THE TURBOVAC 90 AND IT WORKED AND WE FOLLOWED THE SURGERY. NO SIGNIFICANT DELAY WAS REPORTED AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838727 ↗
• MalfunctionJan 5, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PART OF THE BLACK COATING OF THE AMBIENT HIPVAC'S ELECTRODE CAME OFF AS A WHOLE DURING AN ARTHROSCOPY. EVERYTHING WAS REMOVED WITH ARTHROSCOPIC GRASPING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY OF LESS THAT OR EQUAL TO 30 MIN. 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 11116903 ↗
• MalfunctionNov 27, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING SURGERY, AFTER INSERTING AND REMOVING THE AMBIENT WAND SEVERAL TIMES, THE PLASTIC INSULATION ON THE SHAFT WAS SUDDENLY PARTIALLY TORN OFF. THE PLASTIC PARTS HAD TO BE REMOVED WITH THE HELP OF A GRASPING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO DELAY 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 10913867 ↗
• MalfunctionSep 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE AMBIENT HIPVAC 50 IFS WAS PEELED OUT OF THE BOX. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 10514404 ↗
• MalfunctionSep 3, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE AMBIENT HIPVAC WAS FOUND TO NOT BE STERILIZED WHEN IT WAS OPENED. INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS A DELAY BETWEEN 0-30MIN AND A BACK-UP DEVICE WAS AVAILABLE. 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 10489522 ↗
• MalfunctionJun 14, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS A PRESUMPTION THAT THREE (3) "AMBIENT HIPVAC 50° IFS WANDS" WERE PART OF FAULTY LOTS. AS A RESULT, THE FIRST TWO WANDS WERE TESTED ON THE SAME CONTROL UNIT THAT HAS BEEN PREVIOUSLY INVOLVED IN AN ALREADY REPORTED HIP SURGERY, AND SHOWED AN ¿E6 ERROR¿. IN CONSEQUENCE, THE THIRD WAND WAS TESTED ON A DIFFERENT CONTROL UNIT AND IT WORKED. THE INCIDENT OCCURRED DURING INSPECTION OF THESE THREE (3) WANDS. 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 Patient Involvement

  MAUDE report 10151453 ↗
• MalfunctionMay 29, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING HIP SURGERY THE AMBIENT HIPVAC PRESENTED AN ERROR E6 OPEN T/C. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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 Known Impact Or Consequence To Patient

  MAUDE report 10100031 ↗
• MalfunctionMay 29, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING HIP SURGERY THE AMBIENT HIPVAC PRESENTED AN ERROR E6 OPEN T/C. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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 Known Impact Or Consequence To Patient

  MAUDE report 10100011 ↗
• MalfunctionFeb 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY, THE WAND SHOWED AN E7 ERROR CODE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE INSULATION ON THE SHAFT IN THIS UNIT WAS DAMAGED AND COMPROMISED. THIS DAMAGED OF INSULATION MAY LEAD TO TRANSMISSION OF CURRENT TO SKIN OR NON-TARGET TISSUE, WHICH MAY RESULT IN A BURN TO THE PATIENT OR USER 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 9772649 ↗
• MalfunctionFeb 22, 2020Image Display Error/Artifact; Appropriate Device Problem Term/Code Not Available; Image Display Error/Artifact; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HIP SURGERY AN E6 ERROR CODE OCCURRED, SITE HAD TO OPEN ANOTHER ONE TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE INSULATION SHAFT WAS DAMAGED, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742700 ↗
• MalfunctionDec 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A NON-SPECIFIC PART OF THE ELECTRODE HEAD, PRESUMABLY THE INSULATION, HAD COME LOOSE AND WAS FREE IN THE JOINT. THE PIECE WAS REMOVED WITH THE GRASPING FORCEPS AND THE PROCEDURE WAS SUCCESSFULLY 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 Known Impact Or Consequence To Patient

  MAUDE report 9522380 ↗
• MalfunctionJun 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE DEVICE TIP BROKE OFF INTO THE PATIENT . PHYSICIAN ATTEMPTED TO RETRIEVE BUT WAS UNABLE TO VISUALIZE, GIVEN SMALL FRAGMENT, THOUGH NOT LIKELY TO CAUSE HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT IT IS UNKNOWN IF IT WAS COMPLETED WITH THE SAME DEVICE OR ANOTHER DEVICE WITHOUT SIGNIFICANT DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8725698 ↗