PhotonBladeRecalls & reported problems across all models
Stryker Corporation · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 3 models of PhotonBlade by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jun 6, 2017 and Nov 21, 2025 — classified as 2 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Flaked” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PhotonBlade problems
Device problems
- Flaked7
- Unintended Power Up7
- Fracture5
- Adverse Event Without Identified Device or Use Problem4
- Energy Output To Patient Tissue Incorrect3
- Output below Specifications2
- Sparking2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient5
- Superficial (First Degree) Burn5
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
PhotonBlade models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PhotonBlade PB1Electrosurgical, Cutting & Coagulation & Accessories18 reports
- PhotonBlade 0730102000Electrosurgical, cutting & coagulation & accessories15 reports
- PhotonBlade 0730101000Electrosurgical, cutting & coagulation & accessories1 report
Recent PhotonBlade adverse event reports
The 15 most recent reports across all models, 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 23, 2025Sparking; Sparking
UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THIS EVENT IS NOT REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217583 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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