Coblation E2020-01Recalls & reported problems
Smith & Nephew, Inc. · EVAC BENDING TOOL · Class 1
All models of Coblation (62)
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 00817470003567), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Break; Break
IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE EVAC BENDING TOOL SNAPPED OFF. BENDER BROKE WHILE BENDING WAND BEFORE THE PHYSICIAN STARTED COBLATING. THE PIECE DID NOT FALL INTO THE PATIENT. IT BROKE ON THE MAYO. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14637679 ↗
Other INSTRUMENT, BENDING OR CONTOURING devices
- TRIGEN 71674576Smith & Nephew, Inc. · INSTRUMENT, BENDING OR CONTOURING18 reports
- NA 329.30Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING7 reports
- MatrixMANDIBLE 03.503.079Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING4 reports
- NA 388.112Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING3 reports
- NA 388.113Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING2 reports
- MatrixMANDIBLE 03.503.041Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING1 report
- EVOS 71175064Smith & Nephew, Inc. · INSTRUMENT, BENDING OR CONTOURING1 report
- NA 329.24Synthes GmbH · INSTRUMENT, BENDING OR CONTOURING1 report
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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