Electrosurgical Generator ESU-1Recalls & reported problems
Clearstream Technologies Limited · Electrosurgical Generator · Class 2
Data updated Oct 18, 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 00868260000228), received between Aug 31, 2020 and Aug 31, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Cut” (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 18, 2026.
Most reported problems
Device problems
- Failure to Cut1
- Failure to Deliver Energy1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2020Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut
IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA (AVF) PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO CUT THE TISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10470624 ↗
Other Electrosurgical, cutting & coagulation & accessories devices
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- LigaSure LF1937Covidien LP · Electrosurgical, cutting & coagulation & accessories3 deaths2,090 reports
- Olympus WB91051WOLYMPUS Winter & Ibe GmbH · Electrosurgical, Cutting & Coagulation & Accessories1 death1,951 reports
- Valleylab FT10 VLFT10GENCovidien LP · Electrosurgical, cutting & coagulation & accessories1 recall5 deaths1,062 reports
- LigaSure LF1837Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
- LigaSure LF2019Covidien LP · Electrosurgical, cutting & coagulation & accessories948 reports
- VAPR 225028Depuy Mitek, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES895 reports
- LigaSure LF1923Covidien LP · Electrosurgical, cutting & coagulation & accessories855 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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