Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its AMS 700 Spherical Reservoir with InhibiZone and AMS 700 Conceal Reservoir with InhibiZone. The affected devices are identified as the following: -
The manufacturer is voluntarily implementing a medical device removal of certain serial numbers of AMS 700 Reservoirs which may have been incorrectly labeled. Specifically, AMS 700 IZ 100 ml Conceal Reservoirs labeled as Spherical Reservoirs and AMS 700 IZ 100 ml Spherical Reservoirs labeled as Conceal Reservoirs.
According to the manufacturer, the most common potential health consequence of this issue would be a negligible delay in procedure to exchange the Conceal Reservoir for a Spherical Reservoir, or vice versa. Exchange of the device would not result in an adverse consequence to the patient. As both the 100 ml IZ Conceal Reservoirs and the 100 ml IZ Spherical Reservoirs provide sufficient fluid volume to fill all cylinder configurations and sizes, the physician may also elect to implant the reservoir despite the incorrect labeling. The most serious potential health consequence would be a moderate prolongation in the procedure and associated anesthesia if a physician chooses to exchange the Conceal Reservoir for a Spherical Reservoir, or vice versa, and the replacement device is not readily available.
The manufacturer is instructing affected users to remove the affected devices from use.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 30 March 2021