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Recall Observatory FDA recall evidence

Device product

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

Z-1878-2018

March 12, 2018

Class II

Product summary

Firm
Micro-Tech (Nanjing) Co., Ltd.
Event
Event 79911
Status
Terminated
Classification
Class II
Quantity
40 total
Official record key
device-enforcement:Z-1878-2018

Official wording

Reason: 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 the needle in the human body, which could cause injury.

Code information: Identifier EUS-22-0-N UPN ES34601 M171226172

Distribution pattern: US distribution to one distributor in MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 the needle in the human body, which could cause injury.