Medical device manufacturer, Karl Storz, has issued a medical device safety alert concerning its Hysteromat E.A.S.I. [Article Number: 26340020-1; Serial Number: All].
During review of the technical documentation, it was determined that the manufacturer currently does not have sufficient clinical evidence to demonstrate fully the basic requirements of the HYSTEROMAT E.A.S.I. in respect to certain performance characteristics in combination with the associated tubing set. In particular, the pressure value displayed by the device could differ from the actual intracavitary pressure value. In this connection, it cannot be proven at this point in time that the device meets the indicated specifications and certain basic performance characteristics.
There is a risk that a patient may be exposed to a higher pressure than intended. Due to the possibly increased pressure, the general risks of hysteroscopy are more likely to occur than when comparable pump systems are used. According to the manufacturer, no incidents have been reported in connection with the above-described problem in patients who have already been treated with the affected products.
The manufacturer is initiating the recall due to the pressure value displayed by the device could differ from the actual intracavitary pressure value. Users are advised to remove Hysteromat E.A.S.I. from use.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 3 March 2021