Microscopic evaluation revealed that no burr is present on the device.The instrument had been disassembled by unauthorized service company (safety welding broken by application of force on screw, screw slot damaged).Cutting test failed.The device showed excessive wear, the tip and footplate being damaged by unauthorized repair and/or modification, jaw bent.Review of manufacturing records showed no issues.Customer instructed to perform function check of device before reuse and not to use modified instruments.
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Per customer statement, a burr on the side and back of the tip resulted in a tear in the dura.The dura tear was repaired.The patient recovered normally and was discharged with special instructions for a dura tear.Additional information (04/27/2016): the product was not received in this condition.It was being used for a revision right l4/5 lfd when it was observed that it had a burr on the side and back of the tip.The doctor had to do a dura repair, stitching it with 6-0 prolene suture.The patient had to lay flat for 60 minutes.
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