PhotonBlade 0730102000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327629187), received between Jan 21, 2025 and Nov 21, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Fracture; Fracture

  UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE REPORTED EVENT RESULTED FROM USER ERROR.

  Patient problems: Insufficient Information

  MAUDE report 23616547 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE PHOTONBLADE 3 BROKE OFF. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, MEDICAL INTERVENTION, SURGICAL DELAY OR ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23616544 ↗
• MalfunctionOct 30, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAGULATION FUNCTION WAS OUTPUTTING A CUTTING FUNCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425079 ↗
• MalfunctionOct 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PLASTIC PIECE BROKE OFF AND FELL INSIDE PATIENT. THE PIECE WAS REMOVED, PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23233849 ↗
• MalfunctionSep 17, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE THE COAGULATION FUNCTION DID NOT WORK BUT THE CUT FUNCTION DID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073516 ↗
• MalfunctionSep 3, 2025Output below Specifications; Output below Specifications

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951466 ↗
• MalfunctionJul 18, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHOTONBLADE 3SE ACTIVATED WHEN PLACED IN THE HOLSTER WITHOUT PRESSING ANY BUTTONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541497 ↗
• MalfunctionJul 10, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT THE PHOTONBLADE 3 ACTIVATED WHEN PLACED IN THE HOLSTER WITHOUT PRESSING ANY BUTTONS. THERE WAS NO ASSOCIATED PROCEDURE; NO ADVERSE CONSEQUENCES OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467720 ↗
• MalfunctionJul 10, 2025No Device Output; No Device Output

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE COAGULATION FUNCTION ON THE E-SEP SAFEAIR PENCIL DID NOT WORK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467328 ↗
• MalfunctionJun 25, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHOTONBLADE 3SE ACTIVATED WHEN PLACED IN THE HOLSTER WITHOUT PRESSING ANY BUTTONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330317 ↗
• MalfunctionMar 26, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHOTONBLADE 3 ACTIVATED WHEN PLACED IN THE HOLSTER WITHOUT PRESSING ANY BUTTONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700950 ↗
• MalfunctionFeb 24, 2025Flaked; Flaked

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446112 ↗
• MalfunctionFeb 10, 2025Unintended Power Up; Failure to Deliver Energy; Unintended Power Up; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHOTONBLADE 3 DID NOT WORK, AND AFTER ADJUSTMENT THE CUT FUNCTION ACTIVATED WITHOUT PRESSING ANY BUTTONS BY THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343420 ↗
• MalfunctionFeb 4, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHOTOABLATE ACTIVATED WHEN PLACED IN THE HOLSTER WITHOUT PRESSING ANY BUTTONS BY THE NURSE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304735 ↗
• MalfunctionJan 21, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE COATING ON THE TIP OF THE PHOTONBLADE 3 FLAKED DUE TO EXCESSIVE MANIPULATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21199034 ↗