EndoStat 0010-0632Recalls & reported problems
American Medical Systems · 0.3mm 12ft · Class 2
Data updated Oct 13, 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 00878953000060), received between Dec 1, 2020 and Dec 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionDec 1, 2020Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE THE FIBER DETACHED FROM THE WHITE ADAPTER WHEN THE SURGEON FIRED THE LASER. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER AND NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10930506 ↗
Other Powered Laser Surgical Instrument devices
- Moxy 0010-2400Boston Scientific Corporation · Powered Laser Surgical Instrument4,572 reports
- SOLTIVE TFL-PLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls450 reports
- Flexiva TracTip M0068403960Boston Scientific Corporation · Powered laser surgical instrument562 reports
- Moses™ AC-10030100Lumenis Ltd. · Powered Laser Surgical Instrument532 reports
- Flexiva M0068403910Boston Scientific Corporation · Powered laser surgical instrument376 reports
- Visualase 9735542Medtronic Navigation, Inc. · Powered laser surgical instrument1 recall2 deaths311 reports
- SOLTIVE TFL-SLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls33 reports
- NeuroBlate® System 20980Monteris Medical Inc · Powered laser surgical instrument7 deaths296 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 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