Greenwald Surgical Company, Inc. 25910-06Recalls & reported problems
Grace Manufacturing, Inc. · Ball Tip Electrode for rigid Cystoscopes. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801334000806), received between Apr 6, 2021 and May 12, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Improper or Incorrect Procedure or Method1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2021Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method
DESCRIBE THE EVENTO OR PROBLEM: UROLOGIST USING BUGBY BALL TIP ELECTRODE. WHEN HE REMOVED IT FROM THE PATIENT, HE NOTICED THE BALL TIP WAS MISSING. UPON INSPECTION, THE SURGEON LOCATED THE BALL TIP ADHERED TO THE BLADDER. HE WAS ABLE TO RETRIEVE THE BALL TIP WITH NO HARM TO THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CYSTOSCOPY, BLADDER BIOPSY AND FULGERATION. WHAT PROBLEM DID THE USER HAVE : DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).
Patient problems: Foreign Body In Patient
MAUDE report 11814297 ↗MalfunctionApr 6, 2021Component Missing
UROLOGIST USING BUGBY BALL TIP ELECTRODE. WHEN HE REMOVED IT FROM THE PATIENT, HE NOTICED THE BALL TIP WAS MISSING. UPON INSPECTION, THE SURGEON LOCATED THE BALL TIP ADHERED TO THE BLADDER. HE WAS ABLE TO RETRIEVE THE BALL TIP WITH NO HARM TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 11618526 ↗
Other Electrode, Electrosurgical, Active, Urological devices
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- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- 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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