Model Number EG-2990I |
Device Problem
Poor Quality Image (1408)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4) _ the endoscope will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and returned to the customer or loaner inventory as applicable.Model eg-2990i, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 07-feb-2022, a device history record(dhr) review for model eg-2990i, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 29-jun-2011 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 29-jun-2011.The investigation is in-process.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 a complaint that occurred in the united states.The customer reported poor image quality involving pentax medical video gastroscope, model eg-2990i, serial number (b)(4).The event timing and location are unknown.No death or serious injury was reported.This event meets the requirements for fda reportability; however submission of this 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: we checked the returned unit and confirmed that the light guide fiver bundle (lcb) was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the lcb.In addition, we confirmed that the remote control button cracked, and the suction channel kink; however, they are not the main cause, and/or irrelevant to the alleged complaint.Correction information g6: follow up #1.H2: type of follow up.H6: coding changed based on the investigation result.
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Search Alerts/Recalls
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