NA 5100009000Recalls & reported problems
Stryker Corporation · Universal Handswitch · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540074393), received between Jul 24, 2018 and Oct 25, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Remains Activated” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Remains Activated3
- Fail-Safe Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2022Device Remains Activated; Device Remains Activated
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15666722 ↗MalfunctionJul 26, 2022Fail-Safe Problem; Fail-Safe Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15101815 ↗MalfunctionJul 27, 2020Device Remains Activated; Device Remains Activated
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON.1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10329666 ↗MalfunctionOct 28, 2019Device Remains Activated; Device Remains Activated
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 9245327 ↗MalfunctionJul 24, 2018Material Fragmentation; Material Fragmentation
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF; 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714812 ↗
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- NA 5100015252Stryker Corporation · UNIT, OPERATIVE DENTAL42 reports
- TPS 5100008000Stryker Corporation · UNIT, OPERATIVE DENTAL22 reports
- TPS 5100131000Stryker Corporation · UNIT, OPERATIVE DENTAL17 reports
- NA 5100015272Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
- TPS 5100007000Stryker Corporation · UNIT, OPERATIVE DENTAL15 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.