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Catalog Number 7206011 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Injury (2348)
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Event Date 07/24/2019 |
Event Type
Injury
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Event Description
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It was reported that during shoulder arthroscopy surgery, the shaver tip was overheated and burned the patient.A backup device was available to complete the procedure with no delay.The patient outcome is unknown.
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Manufacturer Narrative
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The reported 4.5 mm full radius blade, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blade heated up and burned the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not using the proper amount of irrigation recommended to provide adequate cooling of the blade.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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Search Alerts/Recalls
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