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Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)

Micro-Tech (Nanjing) Co., Ltd. · Model EUS-19-0-FS2 · UDI-DI 06932503534864

ODG Prescription
1
510(k) clearances
16,330
Adverse events (31 deaths)
10
Recalls
40
Facilities

Description

Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1245~1285mm,FNA needle

Recalls

DateFirmReason
2020-10-16Olympus Corporation of the AmericasA new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16Olympus Corporation of the AmericasA new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16Olympus Corporation of the AmericasA new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16Olympus Corporation of the AmericasA new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2018-03-12Micro-Tech (Nanjing) Co., Ltd.The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of
2018-03-12Micro-Tech (Nanjing) Co., Ltd.The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of
2017-05-23Pentax of America IncError in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning
2017-05-23Pentax of America IncError in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning
2016-04-06Pentax Medical CompanyPentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the U
2015-08-21Olympus Corporation of the AmericasInsufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.