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 02/08/2024

Event Type  malfunction  

Event Description

It was reported that, during the photoselective vaporization of the prostate procedure, two fibers broke on the inside of the protection device after several minutes of use.The procedure was then switched to bipolar resection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This report is for the second fiber.

Manufacturer Narrative

This report is for the same event as manufacturer report: 2124215-2024-13809.

Manufacturer Narrative

This report is for the same event as manufacturer report: 2124215-2024-13809.Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual and microscopic examination identified the glass cap was protruding more than usual indicative of a glue failure.Additionally, the tir (total internal reflector) surface was misaligned with the output window due to the glue failure.The fiber was functionally tested with the hene (helium-neon) laser fixture.The testing conducted showed there were no signs of breakages along the length of the fiber.The connector cone, segments, and tabs appear in good condition and are secured.The fiber passed the connector segment verification test.The control knob is attached and aligned with the fiber and can rotate the fiber.It is probable that the glue failure occurred due to inadvertent heavy tissue contact and a decrease in saline flow.The interaction between the user and device caused or contributed to the observed fiber tip damage and reported event.According to the instructions for use, 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.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the reported event of fiber break as analysis did not identify any breakages along the length of the fiber.

Event Description

It was reported that, during the photoselective vaporization of the prostate procedure, two fibers broke on the inside of the protection device after several minutes of use.The procedure was then switched to bipolar resection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This report is for the second fiber.

• 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: 18852455
• MDR Text Key: 337620901
• Report Number: 2124215-2024-13814
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/23/2024

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: 0030639389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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