Medical device manufacturer, Rudolf Medical GmbH, has issued a medical device safety alert concerning its Continuous-Flow Outer Sheath for Resectoscope [Item number: RC260-111, RC220-111].
A customer complaint brought to the manufacturer's attention that during surgery, irrigation was not possible because the irrigation connections on the outer and inner shaft are not in the corresponding place. Further investigation showed that this issue is caused by a general mix-up of the outer shaft geometry. This represents a potential safety risk which could lead to the lengthening or rescheduling of the surgery.
The manufacturer advises affected users to quarantine the concerned items in stock.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 October 2015