VBEAM Prima Laser System 9914-00-9080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817495022963), received between Nov 4, 2024 and Nov 4, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Electrical /Electronic Property Problem; Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible; Electrical /Electronic Property Problem; Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible

  CANDELA CUSTOMER, A DISTRIBUTOR IN NETHERLANDS, REPORTED THAT THERE WAS AN "EXPLOSION" WITHIN A VBEAM PRIMA WHICH OCCURRED DURING PREVENTIVE MAINTENANCE OF THE DEVICE. IT WAS REPORTED THAT THERE WERE NO INJURIES RELATED TO THE EVENT; PCB BOARD WAS BOWED, AND NO FRAGMENTS BREACHED THE SYSTEM. CANDELA TEAM MET WITH CUSTOMER TO FURTHER DISCUSS THE REPORTED EVENT ON 10OCT2024. AT THIS TIME, IT WAS REPORTED THAT THE FIELD SERVICE ENGINEER (FSE) SERVICING THE DEVICE AT THE TIME OF THE MALFUNCTION HAD RINGING IN HIS EARS (TINNITUS) FOLLOWING THE EVENT. HE HAD NOT SOUGHT MEDICAL ATTENTION. PER CANDELA REGULATORY REPORTABILITY DECISION FOR LOUD NOISE OCCURRENCE, THE LASER OPERATES BETWEEN 50 DBA AND 70 DBA DURING NORMAL USE. IF A FAILURE WOULD OCCUR, IT WOULD BE AN IMPULSE ACOUSTICAL NOISE ABOVE 80DBA, BUT BELOW 140 DBA. THE USER OR PATIENT COULD POTENTIALLY BE SUBJECTED TO THE FOLLOWING CONDITION(S): TEMPORARY RINGING OR BUZZING IN EAR, MOST CONDITIONS LASTING LESS THAN 16 TO 48 HOURS. FURTHER FOLLOW UP FROM CUSTOMER ON (B)(6) 2024 REPORTED THAT THE FSE CONTINUED TO HAVE TINNITUS AND HAS SOUGHT MEDICAL ATTENTION. THE FSE FOLLOW-UP NOTES THAT HE STARTED THE ANNUAL PREVENTIVE MAINTENANCE OF

  Patient problems: Tinnitus

  MAUDE report 20601782 ↗