Catalog Number 283512 |
Device Problems
Defective Component (2292); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information should become available, a supplemental medwatch will be submitted accordingly.
(b)(6).
Investigation summary: the device was received at the service center and evaluated.
This reported problem was confirmed.
The defect reported by the customer has been verified.
The diagnostic assessment had been carried out.
As per the service report, the following parts were found to be defective, o-rings, tissue seal set, micro valve screws set, micro motor and jaw kit, lock spring, and micro handcontrol set.
However, service was declined by the customer and hence, the system was not restored to specification.
The root cause for this failure is undetermined.
A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.
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.
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Event Description
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It was reported by the affiliate in (b)(6) that the micro tornado handpiece with hand controls device did not work.
During in-house engineering evaluation, it was determined that the following parts on the device were defective, o-rings, tissue seal set, micro valve screws set, micro motor and jaw kit, lock spring, and micro handcontrol set.
It was not reported if the device was used in surgery, or if there was patient involvement.
It was not reported if there were any delays in a surgical procedure or if a spare device was available.
It was not reported if there were any injuries, medical intervention or prolonged hospitalization.
The exact date of the event was unknown but was noted to have occurred in 2018.
All available information has been disclosed.
If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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