Model Number EG-2990I |
Device Problems
Break (1069); 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 customer owned device will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and returned to the customer.Eg-2990i, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 01-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 miyagi facility on 01-mar-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 01-mar-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 (b)(6).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 ccd module failure.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the insertion flexible tube (ift) fluid damage, the lg cable connector fluid damage, the operation channel resistance, the ccd driver pcb corroded, the control body corroded, the electrical connector corroded, the operation channel leaky, the light guide cable buckled, and the lg cable connector corroded; however, they are not the main cause, and/or irrelevant to the alleged complaint.
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Search Alerts/Recalls
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