SMITH & NEPHEW, INC. SVCE REP DYONICSPOWERMINI HAND CONTROLS; SAW, POWERED, AND ACCESSORIES
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Model Number 72201500S |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported that the dyonics powermini displayed "unknown handpiece" error message.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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Updated, device received the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of unknown handpiece error could not be reproduced.Product passed functional and high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions.Unit passed functional tests on the dii and dii eip test control units with footswitch.Unknown handpiece error did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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