Recall Z-1798-2020 ยท GEX Powered Laser Surgical Instrument
Boston Scientific Corporation
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
| Date | Mar 30, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Use error |
| Action | An Urgent Medical Device Product Advisory - Immediate Action Required dated 3/30/20 was sent to customers. Existing MoXy" laser fiber Direction for Use to be Reinforced 1- Ensure the distance from the fiber to the tissue is approximately 2mm (1 to 3 mm). Reference: Table 2. Troubleshooting and Procedural Considerations in product DFU. 2- 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. 3- Failure to position the saline solution at least 106cm or not opening the flow valve will decrease the |
| Quantity | 146,633 |
| Distribution | Worldwide distribution - US Nationwide and Global distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120870 | GREENLIGHT MOXY FIBER OPTIC American Medical Systems, Jun 15, 2012 |