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Model Number 242018 |
Device Problems
Break (1069); Display or Visual Feedback Problem (1184); Dent in Material (2526); Material Twisted/Bent (2981); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported by the sales rep that the hd epscp,4.0,30,167,mitek endoscope device had cloudy images after it was plugged into a camera and coupler.According to the report, an attempt was made to clean the lenses but did not resolve the issue of the blurry images that the device produced.There was no procedure nor patient involvement reported.No additional information was provided.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the complaint device was received at the manufacturing site and evaluated.It was reported that there are cloudy images after being plugged into a camera and coupler.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: ¿ minor scratches on the unit ¿ outer tube damaged - bent/dented outer tube ¿ distal tip damaged ¿ optical system, optical components - broken lenses in optical system the defective parts were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Search Alerts/Recalls
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