The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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During preparation for a coil embolization procedure, the scrub technologist inadvertently bent a ruby coil pusher assembly while removing the ruby coil from its dispenser hoop.The pusher assembly became bent prior to use and therefore, the ruby coil was not used in the procedure.The procedure was successfully completed using a new ruby coil.
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