The product was disposed of by the hospital and is no longer available for return.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.
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During preparation for a coil embolization procedure, the hospital technician found that the ruby coil (ruby coil) was bent upon removal from the packaging.The damage to the ruby coil was found prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed using three new ruby coils.
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