NA 5450820000Recalls & reported problems
Stryker Medtech K.K. · Universal Handpiece · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Stryker ultrasonic surgical handpiece (Universal Handpiece). There are 42 adverse event reports naming its identifier, mostly describing the device overheating during use or irrigation problems that could lead to overheating; one report mentions a burn, and one describes the device or a cutting accessory fracturing. The reports include 1 injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327291919), received between Jun 20, 2018 and Jul 26, 2023 — classified as 1 injury, 41 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (28 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
Device problems
- Overheating of Device28
- Inability to Irrigate11
- Failure to Infuse2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Patient Involvement11
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient4
- Burn(s)1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2023Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17401361 ↗MalfunctionJul 26, 2023Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17401355 ↗MalfunctionApr 25, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806649 ↗MalfunctionApr 24, 2023Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16801803 ↗MalfunctionJan 29, 2023Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261977 ↗MalfunctionOct 24, 2022Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663669 ↗MalfunctionOct 24, 2022Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663610 ↗MalfunctionJul 26, 2022Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15108018 ↗MalfunctionJul 26, 2022Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15107810 ↗MalfunctionApr 25, 2022Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193315 ↗MalfunctionJan 19, 2022Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289988 ↗MalfunctionJan 19, 2022Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289810 ↗MalfunctionOct 22, 2021Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES(B)(4) MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. (B)(4) EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12680375 ↗MalfunctionJul 21, 2021Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12204179 ↗MalfunctionJul 21, 2021Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12204152 ↗MalfunctionApr 26, 2021Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11729193 ↗MalfunctionApr 26, 2021Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11729120 ↗MalfunctionJan 22, 2021Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11218286 ↗MalfunctionOct 28, 2020Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 8 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748086 ↗MalfunctionOct 28, 2020Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748037 ↗MalfunctionJul 28, 2020Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 10331393 ↗MalfunctionApr 24, 2020Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9997131 ↗MalfunctionApr 24, 2020Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9997114 ↗MalfunctionJan 28, 2020Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9636490 ↗MalfunctionOct 28, 2019Inability to Irrigate; Inability to Irrigate
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED AN IRRIGATION ISSUE THAT COULD LEAD TO OVERHEATING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 9245380 ↗
Other Instrument, ultrasonic surgical devices
- Harmonic ACE HARH36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical4 deaths7,609 reports
- Harmonic HARHD36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical1 recall2 deaths5,037 reports
- Harmonic ACE HAR36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2,726 reports
- Harmonic HAR1136Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2 deaths1,538 reports
- THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls1,373 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls2 deaths1,128 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical2 recalls1 death970 reports
- Harmonic ACE HARH23Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical935 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page