Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device product advisory concerning its GreenLight MoXy Laser Fiber [Material Number (UPN): 0010-2400; GTIN: 00878953005515].

The manufacturer is initiating a product advisory for the GreenLight MoXy Laser Fibers to reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints. Internal bench testing has determined that an increased irrigation flow may increase the liquid cooling effect and may reduce temperature related complaints.

The most common reasonably foreseeable consequence of the identified thermal related issues as identified in the complaints is a clinically minor procedural delay due to the need to exchange the fiber for another. The most serious injury that could potentially occur as result of any of the thermal issues identified is a severe burn. A severe burn could happen if the side firing laser converts to an end firing laser due to damage to the laser tip and the laser beam is directed at tissue that is not intended to be vaporized, however, the probability is remote.

According to the manufacturer, no product is being recalled and users are not required to return product. This advisory has no bearing upon previously completed procedures using MoXy Laser Fibers (i.e. patient follow-up should simply follow the normal course).

Users should be reinforced about the existing MoXy laser fiber DFU:

• Ensure the distance from the fiber to the tissue is approximately 2mm (1 to 3 mm). [Reference: Table Troubleshooting and Procedural Considerations in product DFU]
• Do not bury the tip of the fiber into the tissue. Reduced irrigation flow may result in damage to the fiber. [Reference: Caution in page 3 of product DFU]
• Failure to position the saline solution at least 106cm or not opening the flow valve will decrease the amount of fluid across the fiber end. Decreased fluid flow may limit the lasing time of the fiber. [Reference: Caution in page 3 of product DFU]

Section 8.3 of the MoXy Laser Fiber DFU has been updated to recommend an increased irrigation flow to increase the liquid cooling effect. The updated DFU (8.3 Performing the Procedure) is as follow:

• Ensure user, patient, and personnel in the room are wearing appropriate protective eyewear before using the laser.
• WARNING: Do not press the footswitch without having the appropriate protective eyewear. Pressing the footswitch may activate the laser beam. Activation of the laser beam when not wearing protective eyewear may result in eye injury to the user, personnel in the room, or the patient.
• Connect the tubing from the sterile saline for irrigation solution to the fiber luer lock connector. Position the saline solution at least 106 cm higher than the level of the endoscope/cystoscope. Increased irrigation flow by means of a saline pressure bag (set to 250 mmHg -300 mmHg) will further increase liquid cooling effect and may reduce fiber tip damage.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 2 April 2020