GeniLook 200-105-152Recalls & reported problems
Genicon, Inc. · Class 1
Data updated Oct 18, 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 00877972003922), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
15 other recalls cover devices cleared under the same FDA submission (K982472); they may or may not involve this specific model.
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
- Loss of or Failure to Bond1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2018Loss of or Failure to Bond; Loss of or Failure to Bond
THE TIP OF THE 5MIL BLADELESS OPTICAL TROCAR (GENILOOK) WAS LOOSE. THE ISSUE WAS DETECTED BY THE DOCTOR WHILE PREPARING THE UNIT FOR USE.
Patient problems: No Information
MAUDE report 7741893 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982472. One submission often covers many models, so check the product and lot details in each record.
- Z-2272-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle
- Z-2267-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
- Z-2271-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle
- Z-2273-2020 · Aug 21, 2018 · Open, ClassifiedGenicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troca
- Z-2276-2020 · Aug 21, 2018 · Open, ClassifiedGenicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
- Z-2266-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Tr
- Z-2269-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Tr
- Z-2274-2020 · Aug 21, 2018 · Open, ClassifiedGenicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
- Z-2270-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handl
- Z-2275-2020 · Aug 21, 2018 · Open, ClassifiedGenicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troc
- Z-2279-2020 · Aug 21, 2018 · Open, ClassifiedGenicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Troca
- Z-2268-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar han
- Z-2278-2020 · Aug 21, 2018 · Open, ClassifiedGenicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle
- Z-2277-2020 · Aug 21, 2018 · Open, ClassifiedGenicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle wh
- Z-0622-2009 · Sep 25, 2008 · TerminatedGenicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions
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- NA 03.168.013Synthes GmbH · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY37 reports
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- Monoject 8881540111Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY19 reports
- MOSS 279712500Depuy Spine, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY12 reports
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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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