Greenwald Surgical Company, Inc. 25821-05Recalls & reported problems
Grace Manufacturing, Inc. · Flexible conical tip electrode for rigid cystoscope. Precision machined nickel/silver electrode tip. · 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 10801334003906), received between Nov 18, 2020 and Nov 18, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2020Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method
HOSPITAL REPORTED: THE TIP OF THE CATHETER HAS A METAL END PIECE THAT BROKE OFF DURING THE PROCEDURE. THIS DEVICE WAS BEING USED IN A CYSTOSCOPY CASE AND THE TIP OF THE BUGBEE BROKE OFF. I AM UNSURE OF THE CORRELATION OF THE STERILIZATION AND DEVICE FAILURE. OUR INTERNAL CENTRAL PROCESSING DEPARTMENT HAS NOT IDENTIFIED A POSSIBLE CAUSATION. THIS EVENT WAS A METAL TYPE OF CATHETER USED DURING THE CYSTOSCOPY. THE PACKAGING SEQUESTERED, AND SENT TO ME INDICATED STERILIZATION ROLL, BUT IT (THE EVENT) IS ABOUT A 16 INCH METAL CATHETER.
Patient problems: Insufficient Information
MAUDE report 10864370 ↗
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- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 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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