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 03/06/2024

Event Type  malfunction  

Event Description

It was reported that during a photoselective vaporization of the prostate, a total of three (3) fibers were used.The first fiber broke after 108,295 joules and 10:39 minutes of use.The fiber was replaced, and the case continued with a second fiber; however, this fiber also broke after 218,854 joules and 23:25 minutes of use.The procedure was completed with a third fiber utilizing a total of 625,492 joules and 1:03:07 time of use, with no clinical consequences to the patient.This complaint is for the second fiber.

Manufacturer Narrative

This report is for the same event as manufacturer report: 2124215-2024-17953.

Manufacturer Narrative

This report is for the same event as manufacturer report: 2124215-2024-17953.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber tip identified the glass cap exhibited a distal circumferential fracture.The glass cap exhibited severe devitrification, which is a normal degradation, this occurs through use of the fiber and should not be considered a failure mode.The forward firing test for this device resulted in an output which was below the threshold for potential patient harm.The fiber was also tested with hene laser fixture there are no signs of breakage along length of fiber.Based on analysis results, the fiber showed signs of normal usage.No fiber damage was identified that could have caused or contributed to the reported event.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

Event Description

It was reported that during a photoselective vaporization of the prostate, a total of three fibers were used.The first fiber broke after 108,295 joules and 10:39 minutes of use.The fiber was replaced, and the case continued with a second fiber; however, this fiber also broke after 218,854 joules and 23:25 minutes of use.The procedure was completed with a third fiber utilizing a total of 625,492 joules and 1:03:07 time of use, with no clinical consequences to the patient.This complaint 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: 18983862
• MDR Text Key: 339276628
• Report Number: 2124215-2024-17954
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 0032349617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• 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