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Model Number 284002 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Device was used for treatment, not diagnosis.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.It was reported that the device was faulty and unable to detect the shaver.Per service report, the reported issue of the device was unable to detect shaver was not confirmed.Since other failures are observed, the reported issue of the device was faulty can be confirmed.During evaluation, it was found on the suction side that the follower arm was stuck to the stand off and did not move.It was removed and cleaned and to resolve the issue.Software upgrades were also performed.The device passed all the tests and found to be working according to the specifications.As the reported problem of the device was unable to detect shaver was not confirmed, a root cause for the issue that was experienced by the user cannot be determined.When the follower arm is stuck, the device would not work as expected, therefore is the root cause of the reported problem of the device was faulty.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6) 2018 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.Udi: (b)(4).
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Event Description
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It was reported by the affiliate via cst tool that 9 micro tornado handpieces with hand controls, 2 fms vue pumps, 2 vapr vue generators, and a vapr 3 generator all are faulty.Unknown patient status/ outcome / consequences.No patient consequence description or if there a clinical outcome experienced by the patient (infection, inflammation, etc.).Unknown if other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) was required.Unknown if the patient part of a clinical study.
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Search Alerts/Recalls
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