QUANTUM 2 28168-59Recalls & reported problems
Smith & Nephew, Inc. · RF12000 Q2 SERVICE CONTROLLER-ONLY PACKAGE · Class 2
All models of Quantum 2 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470001594), received between May 26, 2020 and May 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
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
- Image Display Error/Artifact1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2020Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF PROCEDURE, THE SYSTEM WAS WORKING BUT NO PLASMA WAS GENERATED FROM THE WAND. ANOTHER WAND WAS CONNECTED AND AFTER SOME TIME IT SHOWED A F4 HARDWARE FAILURE MESSAGE. NO SIGNIFICANT DELAY WAS REPORTED AND AN EQUIVALENT SURGICAL TECHNIQUE WAS USED TO COMPLETE THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10086521 ↗
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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.
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