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GeniSurge 533-005-945Recalls & reported problems

Genicon, Inc. · 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 00877972002192), received between Jun 7, 2018 and Jun 7, 2018 — 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
  • Detachment Of Device Component1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 7, 2018Break; Detachment Of Device Component

    TWO UNITS OF 533-005-945, LOT 160556-B, FELL APART DURING A LAP COLORECTAL PROCEDURE. THE PARTS WERE SUCCESSFULLY RETRIEVED.

    Patient problems: Foreign Body In Patient

    MAUDE report 7578019 ↗

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