Olympus WA47790ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Versapoint II Electrosurgical Generator non-sterile, reusable · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761086592), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Excessive Heating” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Excessive Heating1
- Flare or Flash1
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.
InjuryApr 14, 2023Flare or Flash; Excessive Heating; Flare or Flash; Excessive Heating
ADDITIONAL INFORMATION WAS OBTAINED. THE INDICATION FOR THE MYOMECTOMY WAS A LARGE MYOMA FOUND ON SCAN. WHEN ASKED HOW LONG THE DELAY WAS, THE USER FACILITY STATED THAT THE OPERATION TOOK A TOTAL OF 145 MINUTES. THEY WERE UNABLE TO SAY EXACTLY HOW LONG THE DELAY WAS, BUT THAT IT WAS PROBABLY ABOUT 3 MINUTES PER EACH LOOP EXCHANGE. IT WAS ALSO STATED THAT SINCE IT WAS A LARGE FIBROID, IT DID A LONG TIME TO REMOVE IT. THE ANESTHESIOLOGIST KEPT THE PATIENT SEDATED AS PER NORMAL. THE PATIENT HAD NO ADVERSE EFFECTS AND WENT HOME THE NEXT MORNING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16743189 ↗
Other Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) devices
- Olympus WA47787AOLYMPUS Winter & Ibe GmbH · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)32 reports
- n.a. 26040GP1-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)30 reports
- n.a. 26055GP1-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)3 reports
- LiNA Bipolar Loop™ BL-200Lina Medical ApS · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)3 reports
- LiNA Bipolar Loop™ BL-160Lina Medical ApS · Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)1 report
- n.a. 26040JB1-SKarl Storz GmbH & Co. KG · COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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