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Catalog Number 80395 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Event Description
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In this event it is reported that 30k fsi-sli-10s insert,pkd is alleged to heat up and get hot.No injury reported.
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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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Manufacturer Narrative
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Returned qty.1 insert, (b)(4), kc, warranty test method / gp005-wi02 inductance: gauge id# (b)(4) due: (b)(6) 2024 result: 3.09 ¿ meets spec ¿ does not meet spec ¿ n/a tip condition: - ¿ meets spec ¿ does not meet spec ¿ n/a stack condition ¿ meets spec ¿ does not meet spec ¿ n/a tested on: g136 gage id# (b)(4) due date: (b)(6) 2024 set pressure: 35 psi water flow: output rate: 35 psi - ¿ meets spec ¿ does not meet spec ¿ n/a spray pattern: - ¿ meets spec ¿does not meet spec ¿ n/a water leak: ¿ hp sealing ring ¿ proximal ring ¿ distal ring ¿ seam leak ¿ n/a vibration: - ¿ meets spec ¿ does not meet spec ¿ n/a grip condition: ¿ meets spec ¿ does not meet spec ¿ n/a other visual observation: insert is good, no fault found.(this is a new insert returned inside the packaged).Also insert was tested on a digital thermometer i.D.#6116a due date: 09/30/2024.The temperature was 92.2° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: ¿ confirmed - ¿ not confirmed.
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Search Alerts/Recalls
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