Model Number EG-3870UTK |
Device Problem
Structural Problem (2506)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to pentax for further evaluation on service order 3137639 where it currently pending evaluation.On 07-jan-2022, a device history record (dhr) review for model eg-3870utk, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 09may2014 under normal conditions, passed all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.If additional information becomes available, a supplemental report will be filed with the new information.
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Event Description
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Pentax medical was made aware of an event which occurred in the pai region involving pentax endoscope model eg-3870utk.In the event reported, the user stated the device insertion tube is worn out.The event timing is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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Evaluation summary: since repair information could not be obtained, the cause of wear of the insertion portion could not be identified.A possible cause is deterioration due to chemicals during reprocessing due to repeated use.
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Search Alerts/Recalls
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