PhotonBlade PB1Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00816728020158), received between Jun 6, 2017 and Oct 18, 2024 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Flaked” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE COATING ON THE TIP OF THE PHOTONBLADE FELL INSIDE PATIENT. 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 20480498 ↗
• MalfunctionMay 1, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING THE PROCEDURE THE COATING ON THE ELECTRODE TIP WAS FLAKING 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 19220899 ↗
• MalfunctionDec 6, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A MASTECTOMY, THE COATING ON THE PHOTON BLADE TIP FLAKED OFF WITHIN TEN MINUTES OF USE. 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 15926954 ↗
• MalfunctionOct 19, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PROTECTIVE COATING ON THE PHOTON BLADE STARTED CHIPPING OFF. IT WAS ALSO REPORTED THAT THERE WAS DELAY OF A FEW MINUTES TO REMOVE THE CHIPS. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631383 ↗
• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE PHOTON BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362326 ↗
• MalfunctionMar 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY BLUE RING AROUND THE LIGHT FELL OFF INTO THE PATIENT. 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 13929376 ↗
• MalfunctionOct 12, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE WHILE THE BREAST WAS OPEN, THE COATING MATERIAL FROM THE PHOTON BLADE FLAKED OFF. 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 12614995 ↗
• MalfunctionJul 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY (B)(6) 2018, DURING A PACEMAKER CHANGE OUT THE INSULATION OF A LEAD WAS ACCIDENTALLY DAMAGED. A REPAIR KIT WAS USED TO FIX THE LEAD INTRAOPERATIVELY. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT AND NO IMPACT TO THE PATIENT. THIS INCIDENT WAS REPORTED TO INVUITY ON (B)(4) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661760 ↗
• MalfunctionMay 16, 2018Device Remains Activated; Device Remains Activated

  DURING A CASE THE PHOTONBLADE REMAINED ACTIVE AFTER THE BUTTON WAS RELEASED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS UNPLUGGED AND THE CASE WAS COMPLETED USING A DIFFERENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520882 ↗
• MalfunctionFeb 8, 2018Break; Break

  TOWARD THE END OF A BI-LATERAL NIPPLE SPARING MASTECTOMY, THE COLLAR THAT LOCKS/UNLOCKS THE TELESCOPING SHAFT BROKE. TWO MAIN HALVES WERE RETRIEVED IMMEDIATELY AND A THIRD SMALLER PIECE COULD NOT BE ACCOUNTED FOR. THE SURGEON DID AN EXAMINATION OF THE SURGICAL CAVITY AND DID NOT SEE A THIRD PIECE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252965 ↗
• MalfunctionFeb 6, 2018Out-Of-Box Failure; Out-Of-Box Failure

  WHEN THE PHOTON BLADE WAS INITIALLY CONNECTED TO THE GENERATOR, A SOLID AUDIBLE TONE WAS EMITTED BY THE ESU. IT WAS OBSERVED THAT THE PATIENT RECEIVED TWO VERY MINOR BURNS. THE CASE WAS COMPLETED USING A SECOND DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 7245971 ↗
• MalfunctionJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AN INVUITY REPRESENTATIVE ON (B)(4) 2017, THAT THE INSULATION OF A LEAD WAS ACCIDENTALLY DAMAGED DURING A BATTERY REPLACEMENT OF AN ICD. A SUTURE SLEEVE WAS APPLIED OVER THE DAMAGED AREA OF THE INSULATION. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT AND NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170453 ↗
• MalfunctionJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AN INVUITY REPRESENTATIVE ON (B)(6) 2017 THAT DURING A BATTERY REPLACEMENT OF AN ICD THE INSULATION OF A LEAD WAS ACCIDENTALLY MELTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170446 ↗
• InjuryJun 29, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  DURING A BREAST BIOPSY PROCEDURE, THE PHYSICIAN NOTED A SMALL AMOUNT OF ENERGY DISCHARGE COMING FROM THE SHAFT OF THE DEVICE. THIS RESULTED IN A SMALL BURN (<1 MM) AT THE OPENING OF THE INCISION. THE DOCTOR REMOVED THE AFFECTED TISSUE AND CLOSED THE INCISION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 6679528 ↗
• MalfunctionJun 29, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  DURING A LUMPECTOMY PROCEDURE, THE PHYSICIAN NOTED A BURN NEAR THE PERI-AREIOLAR INCISION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 6679521 ↗
• MalfunctionJun 29, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  DURING A LUMPECTOMY PROCEDURE, THE PHYSICIAN NOTED A SUPERFICIAL BURN ON THE SKIN. THERE WAS NO FOLLOW-UP TREATMENT REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 6679511 ↗
• MalfunctionJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ICD GEN CHANGE PROCEDURE, THE INSULATION OF A LEAD WAS ACCIDENTALLY CUT. THE LEAD WAS REPAIRED AND ITS FUNCTION WAS TESTED; THE CASE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6679508 ↗
• InjuryJun 6, 2017Therapy Delivered to Incorrect Body Area; Sparking; Therapy Delivered to Incorrect Body Area; Sparking

  DURING A LUMPECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE TELESCOPING WAVEGUIDE FELT HOT. THE PHYSICIAN EXAMINED THE INCISION AREA AND NOTICED A BURN NEAR THE PERI-AREOLA REGION THAT REQUIRED A SURGICAL INTERVENTION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 6614502 ↗