VAPR 225360Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705009374), received between Aug 19, 2018 and Sep 11, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Sparking” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2018Arcing of Electrodes; Sparking; Arcing of Electrodes; Sparking

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE, IT WAS OBSERVED THAT THE VAPR 4.0MM SUCT LGDIAM DEVICE CREATED A SPARK AT BOTH THE GENERATOR END AND THE TIP OF THE ELECTRODE WHEN THE ELECTRODE WAS PLUGGED INTO THE GENERATOR. THE SALES REP REPORTED THAT THE ELECTRODE WAS NOT IN THE PATIENT AT THE TIME AND WAS NOT ACTIVATED. THE SURGEON COMPLETED THE PROCEDURE WITH A SHAVER WITH NO PATIENT CONSEQUENCES OR DELAYS. THE CUSTOMER DISCARDED THE COMPLAINT DEVICES. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864180 ↗
• MalfunctionAug 19, 2018Sparking; Sparking

  IT WAS REPORTED THAT DURING ARCR THE DEVICE DID NOT PERFORM VAPORIZATION. IT WAS ALSO REPORTED THAT THE SURGEON FOUND SOMETHING LIKE A SPARK FROM THE TIP OF THE DEVICE, SO HE STOPPED USING THE DEVICE. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. BY USING A BACKUP DEVICE, THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796262 ↗