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.
Recall
- Recall Number
- Z-1798-2020
- Event Number
- 85356
- Firm
- Boston Scientific Corporation
- FEI Number
- 3005099803
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Use error
- Initiated
- March 30, 2020
- Terminated
- April 5, 2023
- Address
- 300 Boston Scientific Way, Marlborough, MA, 01752-1291
Description
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.
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.
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 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 MoXyTM Laser Fiber DFU has been updated to recommend an increased irrigation flow to increase the liquid cooling effect. The additions to the current DFU are highlighted in blue: 8.3 Performing the Procedure 1. 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. 2. 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. Please complete and return the acknowledgement form to indicate receipt of this letter. Boston Scientific Quality Systems 763-494-1133 [email protected]
Worldwide distribution - US Nationwide and Global distribution.
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