MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-2400

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that during a procedure, the fiber tip fell off before it was put into the patient.The fiber tip was not found.There were no patient complications.

Manufacturer Narrative

Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified the glass and metal caps were detached, and not returned.The level of devitrification could not be determined due to the missing glass cap.The fiber was functionally tested with the hene (helium-neon) laser fixture.The testing conducted did not identify further signs of breaks along the fiber body.The observed condition of the fiber is consistent with fibers that experienced tissue adhesion, constant heavy tissue contact, and/or a decrease in the saline cooling flow, which leads to elevated temperature near the laser beam output window.Based on analysis results and information available, it is probable that the interaction between the user and device, caused or contributed to the observed fiber damage and reported event.The device instructions for use instructs the user to maintain a working distance of 2 mm between the tissue and fiber tip during use and to increased irrigation flow by means of a saline pressure bag (set to 250 mmhg - 300 mmhg) to further increase liquid cooling effect to reduce fiber tip damage.

Event Description

It was reported that during a procedure, the fiber tip fell off before it was put into the patient.The fiber tip was not found.Due to this, the procedure was completed using another fiber.There were no patient complications.

• Brand Name: GREENLIGHT MOXY FIBER OPTIC
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18750392
• MDR Text Key: 336212689
• Report Number: 2124215-2024-10145
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0032102757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1