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Catalog Number D4240 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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A customer reported on (b)(6) 2024 regarding the d4240, ergo 2-button shaver handpiece, stating ¿prev maint, gets hot, no patient injury¿.This non-surgical event had no impact on a patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Event Description
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A customer reported on 27feb24 regarding the d4240, ergo 2-button shaver handpiece, stating ¿prev maint, gets hot, no patient injury¿.This non-surgical event had no impact on a patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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Correction: the spelling of the initial reporter's last name has been corrected in section e.1.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history was reviewed and no relationship to this complaint was found.A device history review (dhr) review was not conducted as the device has been in the field for greater than 12 months.A two-year review of complaint history revealed there has been a total of 18 reports, regarding 18 devices, for this device family and failure mode.During this same time frame 3,105 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 0.006.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.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis, and overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.We will continue to monitor for trends through the complaint system to assure patient safety.
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Manufacturer Narrative
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Device evaluation: the device was not overdue for preventative maintenance.No fault was found with the device.The device was tested and met all specifications.The service history was reviewed and no relationship to this complaint was found.A device history review (dhr) review was not conducted as the device has been in the field for greater than 12 months.(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.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis, and overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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A customer reported on (b)(6) 2024 regarding the d4240, ergo 2-button shaver handpiece, stating "prev maint, gets hot, no patient injury".This non-surgical event had no impact on a patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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