PhotonBlade™ PB1 (UDI 00816728020639)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816728020639), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Energy Output Problem” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 20, 2018Energy Output Problem; Therapy Delivered to Incorrect Body Area; Energy Output Problem; Therapy Delivered to Incorrect Body Area

  A BREAST MASTECTOMY/RECONSTRUCTION PROCEDURE UTILIZED TWO PHOTONBLADE DEVICES, WHICH WERE PERFORMING AS INTENDED. DURING THE MIDDLE OF THE PROCEDURE IT WAS REPORTED THAT ONE PHOTONBLADE DEVICE, WHEN ACTIVATED, WAS OBSERVED TO ACTIVATE THE SECONDARY PHOTONBLADE DEVICE. THE SECONDARY PHOTONBLADE WAS REPLACED WITH A NEW PHOTONBLADE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PHYSICIAN NOTICED A MINOR BURN NEAR THE AXILLA THAT REQUIRED A MINOR SURGICAL INTERVENTION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 7895867 ↗