Natura 210-012-151Recalls & reported problems
Genicon, Inc. · Class 1
Data updated Oct 16, 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 00877972005353), received between May 13, 2019 and May 13, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequate User Interface” (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 16, 2026.
Most reported problems
Device problems
- Inadequate User Interface1
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.
MalfunctionMay 13, 2019Inadequate User Interface; Inadequate User Interface
FROM INCIDENT REPORT: LOSS OF PART OF THE TROCAR WHEN RE-INSTALLING AN INSTRUMENT. NO PATIENT CONSEQUENCE. FOREIGN BODY TO RECOVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8603965 ↗
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
Other Cannula, Surgical, General & Plastic Surgery devices
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- AESCULAP MD610Aesculap, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- ENDOPATH TT012Ethicon Endo-Surgery, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY47 reports
- NA 03.168.013Synthes GmbH · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY37 reports
- NA 214120Medos International Sàrl · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Monoject 8881540111Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY19 reports
- MOSS 279712500Depuy Spine, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY12 reports
- Monoject 8881540133Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY10 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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