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BOSTON SCIENTIFIC CORPORATION · Model M00550010 · UDI-DI 08714729790044

ODG Prescription

510(k) clearances

16,330

Adverse events (31 deaths)

Recalls

Facilities

Description

Endoscopic Ultrasound Aspiration Needle

Recalls

Date	Firm	Reason
2020-10-16	Olympus Corporation of the Americas	A 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
2020-10-16	Olympus Corporation of the Americas	A 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
2020-10-16	Olympus Corporation of the Americas	A 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
2020-10-16	Olympus Corporation of the Americas	A 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
2018-03-12	Micro-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
2018-03-12	Micro-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
2017-05-23	Pentax of America Inc	Error 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
2017-05-23	Pentax of America Inc	Error 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
2016-04-06	Pentax Medical Company	Pentax 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
2015-08-21	Olympus Corporation of the Americas	Insufficient 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.