Model Number MAJ-1985 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The customer called olympus technical assistance center (tac) personnel to report his event.During the call, tac provided the customer with the replacement part number for the o-ring, then transferred the customer to customer service to order his replacement.The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
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Event Description
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The customer reported that his olympus cylinder hose with switch-over valve had compromised high pressure hose connection.According to the initial reporter the o-ring on his unit was bad.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
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Manufacturer Narrative
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This report is being submitted to capture additional information received from the initial reporter.That information is located in b5.Should further information be provided, another supplemental report will be submitted.
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Event Description
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Additional information was received from the initial reporter confirming that the user replaced the o-rings on two maj devices.According to the initial reporter those o-rings did not seal properly, and the co2 tanks were drained overnight.The staff forgot to turn off the tank valve.Reportedly, replacing the o-rings a second time with a proper seal resolved the issue.The customer confirmed there was no patient harm or interruption to the case.The customer did note that a minor leak of co2 was still present when the co2 tank was turned on.Extra o-rings were ordered for him to replace as needed.
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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.Based on the results of the investigation the specific cause of phenomenon could not be identified.The device was not returned to legal manufacturer for evaluation.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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