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.This report is associated with mfr report numbers: 3005168196-2018-01322, 3005168196-2018-01323.The hospital disposed of the device.
|
During preparation for a coil embolization procedure, the hospital staff inadvertently contaminated the ruby coil after it sprung partially off the back table.Next, it was noticed that two new ruby coils were kinked upon removal from their packagings.The damages to the ruby coils were found prior to use and therefore, they were not used in the procedure.The procedure was completed using a new ruby coil.
|