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); Break (1069); Overheating of Device (1437); Firing Problem (4011)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that that during photo vaporization of the prostate (pvp), when 15,000 were being used, the laser beam was coming out laterally and rotating on the same axis.Due to this situation, the fiber ended up burning and it was also reported that it broke.The fiber was replaced and the procedure was completed without reported complications.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis did not identify a fiber break at the tip or within the body of the fiber.Microscope inspection identified that the glass cap was protruding from the metal cap, indicating glue failure.Additionally, there was moderate devitrification in the glass cap and severe charred detritus adhesion on surface of the metal cap.The fiber was functionally tested with the hene (helium-neon) laser fixture and there were no findings to indicate a breakage along the fiber body.The connector cone, segments, and tabs appear in good condition and secured.The control knob is attached and aligned with fiber and can rotate the fiber.Lastly, the fiber underwent the forward firing test, where the glass cap broke and detached from the fiber tip, and the calculated rate of forward firing was above the threshold for potential harm.With all the available information, boston scientific concludes that the reported fiber break was confirmed, as the glass cap broke and detached from the tip upon product analysis, and it is likely that the break occurred due to a crack or partial break during procedure.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 analysis results, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

Event Description

It was reported that that during photo vaporization of the prostate (pvp), when 15,000 were being used, the laser beam was coming out laterally and rotating on the same axis.Due to this situation, the fiber ended up burning and it was also reported that it broke.The fiber was replaced and the procedure was completed without reported 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: 18234133
• MDR Text Key: 329385210
• Report Number: 2124215-2023-66932
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 0031044049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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 Age: 58 YR
• Patient Sex: Male