|
Catalog Number D4240 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/07/2024 |
Event Type
malfunction
|
Event Description
|
The customer reported that the device, d4240, ergo 2-button shaver handpiece, had been used in an unknown procedure on approximately 7mar24 when it was reported, ¿keeps getting hot, no patient impact.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
|
|
Manufacturer Narrative
|
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
|
|
Manufacturer Narrative
|
An evaluation of the returned device found that the unit cable fails ground bond.The unit was repaired, evaluation completed and final tested.The unit met all specifications.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be component failure.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.We will continue to monitor for trends through the complaint system to assure patient safety.
|
|
Event Description
|
The customer reported that the device, d4240, ergo 2-button shaver handpiece, had been used in an unknown procedure on approximately 7mar24 when it was reported, ¿keeps getting hot, no patient impact.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
|
|
Search Alerts/Recalls
|
|
|