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Catalog Number 82005 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022); Activation Problem (4042)
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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 a 30k fsi-sli-fg-10s ins, pkd that no water is coming out and device is heating up.No injury.
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Manufacturer Narrative
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Investigation results: root cause: tip/nozzle clogged (ins105) - tip clogged.Insert tip is clogged, no water flow.Insert will get warm if continue run without water flow as for any insert.Conclusion code: unexpected failure returned qty.1 insert, 82005, 22314-00085549, gf, warranty test method / gp005-wi02 inductance: gauge id# (b)(4) due: 11/30/2024 result: 3.20 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: 03/31/2023 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 tip is clogged, no water flow.Insert will get warm if continue run without water flow as for any insert.Alleged event: confirmed - not confirmed.
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Search Alerts/Recalls
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