Model Number 0375704500 |
Device Problems
Insufficient Cooling (1130); Device Emits Odor (1425); Overheating of Device (1437)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the device heated up during the procedure producing a burnt plastic smell.
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Manufacturer Narrative
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Alleged failure: the complaint should reference that both of the shaver handpieces heated up and felt warm to the touch.There was a smell of burnt plastic.I tested and could not re-create but still would like everything evaluated.Salesforce case number (b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be 1) excessive force applied to the cutter/burr by the user with poor or no suction during use.(excessive force may cause friction due to bur shaft assembly and housing assembly interaction.) (2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the device heated up during the procedure producing a burnt plastic smell.
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Search Alerts/Recalls
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