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 hospital staff noticed that the funnel of the ruby coil detachment handle (handle) was missing upon removal from the packaging.The handle with the missing funnel was noticed prior to use; therefore, the handle was not used for the procedure.The procedure was completed using a new handle.
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