NA 05.001.084Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982129055), received between Feb 22, 2021 and Nov 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM COLOMBIA THAT AT THE BEGINNING OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE AIR HOSE DEVICE WAS TRIGGERED. THE REPORTER FURTHER CLARIFIED THAT THE HOSE EXPLODED. ACCORDING TO THE REPORTER, THE DEVICE WAS REPLACED WITH A SECOND AIR HOSE, WHICH ALSO EXPERIENCED THE SAME ISSUE. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. IT WAS REPORTED THAT THERE WAS A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180843 ↗
• MalfunctionNov 19, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THIS IS DEVICE 1 OF 2 FROM THE SAME EVENT. IT WAS REPORTED FROM COLOMBIA THAT AT THE BEGINNING OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DOUBLE AIR HOSE DEVICE "IS TRIGGERED". DURING FURTHER FOLLOW UP WITH THE REPORTER IT WAS CLARIFIED THAT THE HOSE WAS EXPLODING. THE FIRST SPARE DEVICE EXPLODED TOO. A SECOND SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A FIVE MINUTE DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167327 ↗
• MalfunctionFeb 22, 2021Break; Break

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HOSE OF THE AIR HOSE DEVICE WAS RUPTURED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD AN AIR LEAK AND COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INTERNAL PRESSURE TEST AND CHECK HANDPIECE COUPLING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362095 ↗