Model Number ED34-I10T |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Accessory / object stuck in the operation channel.This event occurred at the time of during inspection.There was no report of patient harm.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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Correction information b4: date of this report g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information d4:unique identifier (udi) h4:device manufacture date.Evaluation summary based on the content of investigated data, it was determined that the potential cause/root cause of failure was insertion of an incompatible accessory into the forceps channel.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 22-aug-2014 under normal conditions.The endoscope was reworked for bending noise including k-pipe replacement and passed required inspections, and was released accordingly.Also, there were no concessions and the dates of approval for shipment and actual date shipped were confirmed for 27-aug-2014.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
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Search Alerts/Recalls
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