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Catalog Number 80395 |
Device Problems
Restricted Flow rate (1248); Overheating of Device (1437); No Flow (2991); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it is reported that 30k fsi-sli-10s insert, pkd insert not spraying water and gets hot.No injury occurred.
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Manufacturer Narrative
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Insert tip is spray a little water flow (it look like is getting clogged).Also insert was tested on a digital thermometer i.D.#(b)(4) due date: on (b)(6) 2023.The temperature was 96.0°f, no fault found.The specification states are not to exceed 118.4°f.
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Search Alerts/Recalls
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