|
Model Number 72200873 |
Device Problem
Connection Problem (2900)
|
Patient Problem
No Information (3190)
|
Event Date 10/05/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that during an acl procedure, if a shaver hand piece is plugged into the controller, and then subsequently plugged it into a different console, the port where it is plugged into stopped working.Procedure was completed with a competitor device with no significant delay.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and port a was observed to be damaged.Functional testing could not be performed on port a due to damage.Product failed functional testing with blade stall error in port b only.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 review of the instructions for use revealed the following warnings and precautions related to the reported failure: 1) when connecting peripheral and accessory devices to the dyonics power ii control unit, use only cables that have been validated for use with the control unit.Non-validated cables may damage the control unit and create electrical hazards.The use of non-validated cables will void the warranty.2) check that the electrical equipment is properly grounded (i.E., plugs contain a ground prong).Grounding reliability can be achieved only when the control unit is connected to an equivalent ac power receptacle marked ¿hospital only¿ or ¿hospital-grade.¿ a review of risk management files found that the reported failure was documented appropriately.No containment or corrective actions are recommended at this time.
|
|
Search Alerts/Recalls
|
|
|