Model Number CYF-VH |
Device Problem
Loose or Intermittent Connection (1371)
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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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The returned device was evaluated.Inspection found loose biopsy port.Scratches on video connector and scope connector were also noted.This report will be supplemented accordingly following investigations.
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Event Description
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The user facility reported that the device biopsy port is loose.The issue found during reprocessing.No patient involvement, no user injury reported due to the event.
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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 investigation.The following sections were updated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, biopsy port was damaged and loosened by use handling.The phenomenon was not attributed to the product or manufacture and confirmed it was not a safety issue (not prone to occur).As stated on the ifu (instruction for use) the user manual states: if any irregularity is observed on the biopsy valve of the forceps/irrigation plug, replace it with a new biopsy valve.A damaged or deformed biopsy valve can reduce the efficacy of the air/water feeding function and may cause fluid to leak or spray from the forceps port of the forceps/irrigation plug.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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