Model Number GF-UCT180 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Event Description
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Customer reported image issue, blurry image, crystals were broken.The issue found during an unspecified procedure.There was no patient impact or harm reported due to the event.No user injury reported.Device return evaluation found the c-body (bending section) forceps cover glue peeling.
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Manufacturer Narrative
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The subject device was received and evaluated.Inspection found multiple broken elements on the um (ultrasound image).The customer reported issue was confirmed.Furthermore, peeling was observed on the c-body (bending section) forceps cover glue and crack was noted on the a-rubber.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the adhesive peeling on the distal end could not be identified olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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