Skip to content

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 ↗

Other Laparoscope, General & Plastic Surgery devices

All Laparoscope, General & Plastic Surgery devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.