The Medicines and Healthcare Products Regulatory Agency (MHRA) of United Kingdom posted a medical device safety alert concerning Modulith SLX-F2 manufactured by Storz Medical. The affected serial numbers are 0R.079, 0R.269, 0R.110 and 0R.299.
The system includes a table insert from carbon fibre as part of the optional urology kit. The manufacturer has observed that due to the addition of tolerances of the table insert and the table cutout, the table insert can slip out of place.
During patient treatment the slipping of the insert plate can lead to a sudden downward movement of the patient. According to the manufacturer, this patient movement will be compensated by the patient foil after a few centimeters. Nevertheless, if at this moment an endoscopic instrument is inserted into the patient, serious injury may occur.
To prevent the risk of injuries, the manufacturer advises that user must make sure that the lithotripter is no longer operated in combination with the actual carbon fibre insert plate.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-22-february-to-26-february-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 March 2016