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 11/19/2021 |
Event Type
malfunction
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Event Description
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This device was returned for repair by the customer for a leak observed 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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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 k-lever is leaking when manipulated and the distal end rubber cover glue is chipped.The scope connector is loose.The user¿s complaint of leak was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, external damage was observed at the distal end.However, the definitive root cause of the reported issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.¿ it was confirmed that the subject device met its standards at the time it was shipped.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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