PhotonBlade with Adaptive Smoke Evacuation PB2SERecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00816728021261), received between Nov 8, 2021 and Sep 3, 2025 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Fracture” (29 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951465 ↗
• MalfunctionSep 11, 2024Flaked; Fracture; Flaked; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THAT THE PHOTON BLADE¿S INSULATION DELAMINATED OFF ELECTRODE TIP AND PLASTIC ON SMOKE EVACUATION LINE BROKE OFF. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194387 ↗
• MalfunctionSep 9, 2024Flaked; Flaked

  IT WAS REPORTED THAT PROTECTIVE COATING ON THE TIP CAME OFF DURING A SURGICAL PROCEDURE. 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 20170414 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE PLASTIC CLIP HOLDING THE SMOKE EVACUATION TUBING TO THE PHOTONBLADE BROKE OFF. 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 19716174 ↗
• MalfunctionJul 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIP THAT HOLDS THE SMOKE EVACUATION TUBING TO THE PENCIL BROKE OFF. 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 19666832 ↗
• MalfunctionJul 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIP THAT HOLDS THE SMOKE EVACUATION TUBING TO THE PENCIL BROKE OFF. 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 19666826 ↗
• MalfunctionMay 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE CLIP THAT HOLDS THE SUCTION TUBE TO THE PHOTONBLADE BROKE OFF. 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 19382751 ↗
• MalfunctionMay 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A BREAST SURGERY, A CLIP HOLDING THE SMOKE EVACUATION TUBING TO THE PHOTONBLADE BROKE OFF. THE DOCTOR IS UNSURE IF THE CLIP FELL INTO THE PATIENT OR NOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287844 ↗
• MalfunctionMay 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE CLIP ATTACHING THE SUCTION TUBING TO THE PHOTONBLADE HAND PIECE BROKE OFF AND FELL INTO THE PATIENT'S WOUND. THE SURGEON HAD TO REMOVE THE PLASTIC PIECE FROM THE SURGICAL SITE. 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 19238740 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIP HOLDING THE SMOKE EVACUATION TUBING TO THE PHOTON BLADE BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS EVENT #1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038017 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIP HOLDING THE SMOKE EVACUATION TUBING TO THE PHOTON BLADE BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS EVENT #2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038010 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO CLIPS THAT ATTACHES THE SMOKE EVACUATION TUBING TO THE PHOTON BLADE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352600 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CLAMP ON THE PHOTON BLADE THAT ATTACHES THE SMOKE TUBING BROKE, THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE SURGICAL SITE RESULTING IN A FIVE TO TEN MINUTES DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255434 ↗
• MalfunctionNov 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, PART OF A PHOTON BLADE WITH ADAPTIVE SMOKE EVACUATION BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132401 ↗
• MalfunctionSep 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CLAMP THAT ATTACHES THE SMOKE TUBING TO THE PHOTON BLADE MELTED AND FRACTURED IN 3 DIFFERENT PROCEDURES. IT WAS FURTHER REPORTED THAT FOR ALL 3 PROCEDURES, THERE WAS A TOTAL DELAY OF 2 HOURS TO RETRIEVE THE FRAGMENTS AND ENSURE NO FRAGMENTS REMAINED IN THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS MDR REPORT IS FOR THE SECOND EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802204 ↗
• MalfunctionSep 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CLAMP THAT ATTACHES THE SMOKE TUBING TO THE PHOTON BLADE MELTED AND FRACTURED IN 3 DIFFERENT PROCEDURES. IT WAS FURTHER REPORTED THAT FOR ALL 3 PROCEDURES, THERE WAS A TOTAL DELAY OF 2 HOURS TO RETRIEVE THE FRAGMENTS AND ENSURE NO FRAGMENTS REMAINED IN THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS MDR REPORT IS FOR THE THIRD EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17801873 ↗
• MalfunctionSep 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CLAMP THAT ATTACHES THE SMOKE TUBING TO THE PHOTON BLADE MELTED AND FRACTURED IN 3 DIFFERENT PROCEDURES. IT WAS FURTHER REPORTED THAT FOR ALL 3 PROCEDURES, THERE WAS A TOTAL DELAY OF 2 HOURS TO RETRIEVE THE FRAGMENTS AND ENSURE NO FRAGMENTS REMAINED IN THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS MDR REPORT IS FOR THE FIRST EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17800321 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE PLASTIC CLIP ON THE PB2SE BLADE BROKE. 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 17423921 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE C-CLAMP ON THE PB2SE BLADE BROKE, THE FRAGMENT WAS RECOVERED FROM THE SURGICAL SITE. 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 16625152 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE C-CLAMP ON THE PB2SE BLADE BROKE, THE FRAGMENT WAS RECOVERED FROM THE SURGICAL SITE. 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 16624967 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE C-CLAMP ON THE PB2SE BLADE BROKE, THE FRAGMENT WAS RECOVERED FROM THE SURGICAL SITE. 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 16624965 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE C-CLAMP ON THE PB2SE BLADE BROKE, THE FRAGMENT WAS RECOVERED FROM THE SURGICAL SITE. 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 16624963 ↗
• MalfunctionMar 13, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE PLASTIC CLIP BROKE AND FELL INTO THE PATIENT, THE BROKEN FRAGMENT WAS RETRIEVED. 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 16528493 ↗
• MalfunctionNov 28, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A MASTECTOMY, THE COATING ON THE PHOTON BLADE FLAKED OFF. 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 15874599 ↗
• MalfunctionApr 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CLIP FELL OFF THE PHOTON BLADE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210575 ↗