The customer reported that the ultrathane amplatz ureteral stent set failed.Additional information regarding the failure was later received: when the device was removed from the packaging, the string was knotted and not usable.The customer also confirmed that the device did not make any patient contact; accordingly, no patient adverse events were precipitated by the event.The device is reportedly available for return and evaluation; however, as of the date of this report, no device has yet been received for investigation.
|
Blank fields on this form indicate the information is unknown, unavailable or unchanged.After further review of the event, it was determined that the potential for serious injury is remote as a detailed search of available risk documents has not indicated a heightened patient risk as a result of the reported failure mode.Additionally, a detailed search of current reporting software has not indicated a past precedence setting event.
|