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 Type
malfunction
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Manufacturer Narrative
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Event date is (b)(6) 2021.The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the forceps cover glue was peeling.Additionally, the biopsy channel is leaking, the angle wire is stretched causing low angulation.The user¿s complaint of angulation issues is confirmed.The customer label is covering the olympus caution label.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
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Event Description
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Customer returned this device for repair for the issue of angulation knob functionality causing delayed bending during reprocessing.There is no patient involvement and no harm reported to any patient.During the time of the device evaluation, it was observed that the forceps cover glue was peeling.This medwatch is being submitted for the reportable malfunction of forceps cover glue peeling observed during evaluation.
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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 3 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the forceps cover glue peeling 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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