Medical device manufacturer, Philips Medical Systems, has issued a medical device safety alert concerning its Philips Fetal Spiral Electrode (Reference Number: 9898 031 37631).

Beginning in 2018, the manufacturer has noted an increase in the number of reports of tip breakage received from customers. During use of the Philips Fetal Spiral Electrode (FSE), it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

According to the manufacturer, the affected products meet their specifications and may continue to be used. Clinicians should follow the directions in the Instructions for Use (IFU) to visually examine the FSE upon removal from the newborn scalp to verify the tip is intact. If, upon removal of the affected product from the newborn scalp it is noted not to be intact, appropriate measures to locate and remove the missing part should be taken.

Clinicians should also review the following information from the device's IFU:

• Do not pull the Spiral Tip from the fetal skin and pull the FSE wires apart.
• Do not over-rotate Spiral Tip during attachment.
• Inspect the Spiral Tip to ensure that it is still attached to the FSE Hub. If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique.

The manufacturer is continuing to monitor the incidence of FSE tip breakage.

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 actions.

Posted on 6 March 2019