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Catalog Number BLACKMAX-N |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2013 |
Event Type
malfunction
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Event Description
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It was reported that during an unspecified surgical procedure it was discovered that there was an "air leak" in the hose of the motor device.It was unknown to the reporter if the leak was proximal or distal to the motor device.There were no delays to the planned surgical procedure as a spare identical device was available for use.The reporter indicated that the "patient was not affected." no patient harm, adverse outcome or injury was alleged.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation. (b)(4) evaluated the device and the reported condition was not duplicated or confirmed. therefore, an assignable root cause was not determined. if additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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