Model Number BD-400P-1880 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided.
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Event Description
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The customer reported that the balloon broke and another scope and another balloon had to be used to complete the esophageal dilation procedure.This caused a 10 minute delay but the procedure was completed successfully without impact to the patient.No medical intervention was required.There were no reports of harm.
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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 and device evaluation.The device appears to be heavily damaged on the distal end.There are large missing portions of plastic tubing, causing a large exposure to the metal wire.In addition, the entire balloon has been removed from the device and was not found in the device return.Due to the damage of the received device functional testing was not possible.In addition, the entire balloon has been removed from the device and was not provided for evaluation.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, the root cause of the reported event is unable to be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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