(b)(4).Alleged failure: " during a surgery, no dilatation of the uterine cavity.No pressure.The surgeon and the medical staff had to complete the procedure manually which led to a long surgical delay (1 hour)".The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be pump height, surgery height, tubing was kinked, or a very narrow instrument was used.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
|