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

Model Number 0010-2400

Device Problem Break (1069)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that, during the photoselective vaporization of the prostate procedure, the physician observed a fracture on the tip of the fiber after it had been used for 359,537 joules.It was noted that there were no stone/calculi in the prostate.The flow valve was opened and fluid was observed to be exiting the metal cap window.There was no excessive tissue accumulation on the fiber tip that required cleaning.Pressurized saline was used.The fiber was replaced, and the procedure was completed using a second fiber.There were no patient complications.

Manufacturer Narrative

Upon receipt of this fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual analysis identified a distal circumferential fracture at the glass cap.A distal circumferential fracture has the potential for forward firing; therefore, the reported event is confirmed.The fiber was tested using the forward firing test fixture.The testing found that the rate of forward firing was 1 percent, which is below the threshold for potential patient harm.It is probable that the identified debris adhesion on the surface of the metal cap contributed to elevated temperatures near the laser beam output window leading to the fiber damage.The device instructions for use (ifu) instructs to maintain adequate saline cooling flow to reduce heat accumulation at the fiber tip.Corrected information provided in e4 - initial reporter also sent report to fda.

Event Description

It was reported that, during the photoselective vaporization of the prostate procedure, the physician observed a fracture on the tip of the fiber after it had been used for 359,537 joules.It was noted that there were no stone/calculi in the prostate.The flow valve was opened and fluid was observed to be exiting the metal cap window.There was no excessive tissue accumulation on the fiber tip that required cleaning.Pressurized saline was used.The fiber was replaced, and the procedure was completed using a second 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: 19131104
• MDR Text Key: 340450963
• Report Number: 2124215-2024-23391
• Device Sequence Number: 1
• Product Code: GEX
• 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: 05/31/2024

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: 0032134501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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