This model is not distributed in the united states, therefore 510k is not applicable.We do have similar model eg29-i10c-us available in the united states with a 510k number k190805.(b)(4).This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.If additional information becomes available, a supplemental report will be filed with the new information.
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Pentax medical was made aware of a complaint which occurred in the emea region reporting "the a/w[air water] connector at the lg plug is loosened and leaky" involving pentax medical video gastroscope model eg29-i10c, serial number (b)(4).The event was reported to occur in the operating room, before use.There was no report of death, serious injury or other significant/important medical event.The a/w connector must be fastened and the endoscope must be checked because of a potential fluid damage as part of the service request.This event is fda reportable due to the lack of information to justify that this event would not cause or contribute to a serious injury or other adverse event.
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