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

Model Number 0010-2400

Device Problems Loss of or Failure to Bond (1068); Device Displays Incorrect Message (2591)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber identified the tip of the glass cap was detached; therefore, the reported event is confirmed.It is probable that the glass cap detachment occurred due to elevated temperatures, near the laser beam output window.The increase in temperature can be caused by tissue adhesion from constant and heavy tissue contact and/or a decrease in the saline cooling flow.Continuous elevated temperatures can lead to fiber damage, including glass cap detachment.According to the instructions for use, increasing the 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.Based on the information available and analysis results, the interaction between the user and device caused or contributed to the observed fiber tip damage and reported event.

Event Description

It was reported that during a photoselective vaporization of the prostate (pvp) procedure, the fiber tip was rotating, but it was still remained attached to the fiber after 98,436 joules and 9 minutes of use, and there was a fiber life courtesy message.The product investigation performed confirmed the glass cap was detached.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: 18464801
• MDR Text Key: 332979189
• Report Number: 2124215-2023-75404
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K120870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 0031587924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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
• Patient Sex: Male