NA 2260003Recalls & reported problems
Richard Wolf GmbH · HF SURGERY GENERATOR 400KHZ for Urology, Gynecology, Surgery, for the connection of monopolar and bipolar accessories, international version for USA, monopolar connection Bovie, 3-pin, 4mm plug, bipolar connection, Erbe, Valleylab, touch screen, color display, compatible with core nova, connection socket for neutral electrode cable international, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 300x159x416 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207063392), received between Sep 30, 2026 and Sep 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Activation Failure” (2 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.
Reports received per month
Most reported problems
Device problems
- Activation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952210 ↗InjurySep 30, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952152 ↗
Other Electrosurgical, cutting & coagulation & accessories devices
- Vasoview Hemopro 2 VH-4000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories6 recalls1 death3,232 reports
- 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 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