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Model Number 284004 |
Device Problems
Display or Visual Feedback Problem (1184); Increase in Pressure (1491)
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Patient Problems
Extravasation (1842); Swelling/ Edema (4577)
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Event Date 04/26/2022 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: udi: (b)(4) incomplete.The lot number was unknown.The serial number was unknown; therefore, the manufacturing site name and device manufacture date were unknown.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 sales rep that during a shoulder scope procedure on (b)(6) 2022, while using a fms vue ii fluid management and tissue debridement system device, it was observed that the inflow setting had too much flow and very little visualization.According to the report, the settings were brought down but the shoulder was too swollen.The status of the patient was unknown.No additional information was provided.
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 medatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device was received at the service center and evaluated.During the service evaluation, no defects were identified.Hence, this complaint cannot be confirmed.After repair, the device was found to be working according to the specifications.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.Since the reported condition is not confirmed and no defects were identified, the root cause for the reported failure cannot be determined.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.Device history review : manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: d4: the serial number was reported as unknown on the initial report; and has been updated accordingly.
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Search Alerts/Recalls
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