The device was not returned and no photos were provided.Per risk-0006 rev.02, the complaint may be associated with the following potential failure mode: potential failure mode: user fails to remove the device from the cervical os.Potential effects: device fragments left in patient.Harms: foreign body in patient.Severity: 4.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor".No root cause can be determined because the complaint is not confirmed.
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