HSA would like to alert healthcare professionals to overseas reports of the distribution of counterfeit LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES (Product Code LT300) manufactured by Ethicon Endo-Surgery (EES). Although HSA and the local authorised distributor, Johnson & Johnson Pte Ltd, have not received any reports of counterfeit clips being distributed locally, HSA would like to alert healthcare professionals to the possibility that they may have obtained counterfeit clips if these were purchased from unauthorised sources. As the performance, mechanical properties, biocompatibility and sterility of the counterfeit clips are unknown, HSA strongly discourages the purchase of these products from unauthorised sources.
LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES are registered in Singapore for use on tubular structures or vessels wherever metal ligating clips are indicated.
Background
The counterfeit product was discovered as a result of an investigation by EES. It was purchased in the United States from an unauthorised distributor. EES is working closely with the US Food and Drug Administration (FDA) to investigate this matter and help to prevent further distribution of the counterfeit device.
HSA's actions and advisory
HSA had requested the authorised local distributor to disseminate a letter of notice on the counterfeit device to its customers. In addition, HSA advises healthcare professionals who may have obtained the clips from sources other than the authorised local distributor on the following:
- Carefully examine all LIGACLIP® products before use and also inform the relevant staff in the operating room to do likewise.
- Quarantine any product suspected to be a counterfeit to halt further distribution.
- Contact the authorised local distributor, Johnson & Johnson Pte Ltd to confirm if the suspected product is a counterfeit. If the product is a counterfeit, please report it to HSA via Email: hsa_medical_device@hsa.gov.sg or Tel: 6866 3560.
- Verify the origin of the EES product by contacting the source if it was not purchased from EES directly or Johnson & Johnson Pte Ltd
- Avoid the purchase of products from unauthorised sources (eg, internet sources).
Please refer to the HSA ADR News bulletin by clicking here456 KB for details on how to identify the counterfeit products.
Healthcare professionals are encouraged to report any adverse events suspected to be related to counterfeit LIGACLIP® products to the Vigilance Branch of HSA. More information about the counterfeit products is also available on EES website at www.ees.com/counterfeit.