Model Number 10-550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Lot and serial number of the device not provided by the complainant, therefore the udi, expiration and manufacturing dates are not known.
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Event Description
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It was reported that during a myosure procedure on december 2nd, myosure control unit was powered on and almost instantly the window display goes out and the device won't cut.In many cases were not even attempted to be used and no foot pedal was activated.The case was about two hours in length and patient went from local anesthesia to general.
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Manufacturer Narrative
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Results from the investigation of the product : controller passed functional testing.Complaint not verified.This observation will be monitored and trended.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.
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Search Alerts/Recalls
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