Catalog Number AE05ML |
Device Problems
Misfire (2532); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the product used by a doctor who has experienced faults before.Reported ae05 was misfiring and jamming similar to other products.
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Manufacturer Narrative
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(b)(6).Per dhr the product auto endo5 ml lot # 73d1900710 was manufactured on (b)(6)2019 a total of 288 pieces.Lot was released on (b)(6) 2019.Dhr investigation did not show issues related to complaint.Revision of fmea-08-029 rev 04 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
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Event Description
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It was reported that the product used by a doctor who has experienced faults before.Reported ae05 was misfiring and jamming similar to other products.
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Search Alerts/Recalls
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