Catalog Number 7607 |
Device Problems
Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This is an initial report.The device has not been returned from the patient, so the investigation has not yet been started.However this is a new phenomenon that we have not seen before.All devices are inspected after injection molding and then manually handled in production before sent to customer so this is deemed as an isolated event and will be investigated as soon as the product has been returned.
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Event Description
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This is the information that was received from the atos medical local representative: the product was in 6 weeks from purchase, pt removed one pm to clean and noticed piece missing at that time she coughed and felt something fly out (assumption the missing piece).Actual date of event not recalled, item bought at the (b)(6) clinic (b)(6) 2017.Pt used h2o & hydrogen peroxide for cleaning as per teaching.Pt uses water based lubricant to ease insertion.
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Manufacturer Narrative
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This is an follow up report after we received the device in question for evaluation.Investigation: the provox larytube was visually inspected and it is seen that the larytube has a piece missing at the end of the tube.Conclusion/action: the silicon, which the larytube is made of, can resist extremely high pull force before being torn apart, but if there is a small fraction from where the tear has started this could quite easily be larger.Since the patient has not used the larytube for more than six weeks the suggested cause of the damage would be that the larytube has come in contact with something sharp either when it has been cleaned by the customer or in some other way.Even though it is a lot easier to pull the material apart with a beginning fraction compared to just pulling the material apart, it still needs some force to create the kind of damage seen in this complaint.This is a new phenomenon that we have not seen before.All devices are inspected after injection molding and then manually handled in production before sent to customer so this is deemed as an isolated event.Correction in this report: the date of this report is changed from 09 may 2017 to 10 may 2017.
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Event Description
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This is the information that was received from the atos medical local representative: the product was in 6 weeks from purchase, pt removed one pm to clean and noticed piece missing at that time she coughed and felt something fly out (assumption the missing piece).Actual date of event not recalled, item bought at the (b)(6) clinic (b)(6) 2017.Pt used h2o & hydrogen peroxide for cleaning as per teaching.Pt uses water based lubricant to ease insertion.
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Search Alerts/Recalls
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