VersaCut HandpieceRecalls & reported problems
Lumenis Ltd. · Class 2
- 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 07290109141640), received between Mar 31, 2019 and Mar 31, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Intermittent Loss of Power” (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
- Intermittent Loss of Power1
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.
MalfunctionMar 31, 2019Intermittent Loss of Power; Intermittent Loss of Power
A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED, "INTERMITTENT BEHAVIOR OF A VC HANDPIECE OCCURRED DURING A PROCEDURE. AS THE FACILITY DID NOT HAVE A SECOND HANDPIECE, THE PROCEDURE WAS COMPLETED BY USE OF AN "ELECTRO-PROSTATECTOMY". NO REPORT OF PATIENT INJURY WAS RECEIVED, AND THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S STATUS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8468016 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.