Catalog Number 9560524 |
Device Problems
Device Inoperable (1663); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient was pre-operatively diagnosed with lumbar disc herniation and underwent micro endoscopic discectomy.During the surgery, the flexible arm could not be fixed firmly due to wear of thread.The product came in contact with the patient.No patient complications were reported as the result of the event.There was a delay of less than 60 minutes.
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Manufacturer Narrative
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Product analysis: visual and functional evaluation revealed that the tension wheel and the mating threads are all that were returned.The interfacing threads have been damaged from what appears to be torsional overload.The tightening of the flex arm can place high pressure on the threads that can cause them to be damaged.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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