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Model Number BF-PE2 |
Device Problems
Peeled/Delaminated (1454); Failure to Clean Adequately (4048)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was observed during the device inspection, that the bronchofiberscope exhibited foreign material in bending section cover, the adhesive on the bending section cover, and connecting tube.The bending section cover also had peeling.There were no reports of patient involvement.
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Manufacturer Narrative
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The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of 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 5 years since the subject device was manufactured.Based on the results of the investigation, the existence of foreign material at the bending section cover, the adhesive of the bending section cover, and the connecting tube was confirmed.The foreign material was not able to be identified, and the likely cause of these malfunctions is presumed to be insufficient reprocessing due to leak at the bending section cover.The investigation also confirmed that the bending section cover exhibited peeling.It is likely this malfunction was cause by physical/chemical stress applied to the insertion section during device handling by the user.The following is included in the instructions for use (ifu): for foreign material at the bending section cover, adhesive of the bending section cover, and connecting tube: user may detect the suggested events by handling device in accordance with the following ifu.Preparation and inspection of the endoscope; user may reduce/prevent occurrence of the suggested events by handling device in accordance with the following ifu: leakage testing.For peeling of the bending section cover: user may detect the suggested event by handling device in accordance with the following ifu.Preparation and inspection of the endoscope; leakage testing.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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