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Model Number 284580 |
Device Problems
Increase in Pressure (1491); Overfill (2404)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported by the sales rep that during a knee arthroscopy procedure on (b)(6) 2020, it was observed that the pressure was too high on the pump/shaver device that it would not stop filling the chamber on the device.The same device was used to complete the procedure without delay.There were no adverse patient consequences reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the pressure is too high and nonstop filling of the chamber occurs while using the unit, was confirmed.It was found during evaluation that worn fingers on complete pressure adjusters is causing the reported pressure issue.There were also minor scratches on the device identified during decontamination.The service of the device was however declined and was placed into long-term hold as it was not needed for the equipment exchange pool use.The minor scratches on the device are most likely a result of user mishandling of the device.The worn fingers are a result of prolonged usage of the unit over time.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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