MEDOS INTERNATIONAL SARL FMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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Model Number 284004 |
Device Problems
Increase in Pressure (1491); Overfill (2404)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/09/2023 |
Event Type
malfunction
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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: udi: (b)(4).E3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.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 an anterior cruciate ligament reconstruction procedure on (b)(6) 2023, a management device was used.According to the report, the device continued to read high pressure.It was reported that they recycled the power but the problem remained.It was reported that no fluid was dripping into the chamber.Another like device was used to complete the procedure with 3-5 minute delay.There were no adverse patient consequences reported.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 medwatch, 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 the following defects were identified: functional : does not function.Visual : deformed/bent.Per service reports, this complaint can be confirmed.The repair of the device was however declined as and it is being placed into long term hold.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure 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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Search Alerts/Recalls
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