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); Firing Problem (4011)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that at the beginning of the procedure, at around 80 joules, the glass tip was loose and the fiber tip was rotating.The laser ended up shooting through the cap.The physician used the fiber until it stopped working.The provided picture by the customer shows the fiber tip detached.The procedure was completed using transurethral resection of the prostate (turp) without patient complications.

Manufacturer Narrative

The fiber was not returned for analysis; however media was provided by the customer.The media shows the glass tip is detached and the metal cap exhibits severe charred debris adhesion, indicative of prolonged tissue contact; therefore, the reported event is confirmed.The observed condition of the fiber is consistent with fibers that experienced tissue adhesion, constant heavy tissue contact, and/or a decrease in the saline cooling flow, which leads to elevated temperature near the laser beam output window.Continuously elevated temperature can lead to fiber damages, including glass tip detachments.The review completed on the device history review (dhr) for this console confirmed that it met specification prior to release.The instruction for use (ifu) instructs the user to maintain a working distance of 2 mm between the tissue and fiber tip during use and to increase irrigation flow by means of a saline pressure bag (set to 250 mmhg - 300 mmhg) to further increase liquid cooling effect to reduce fiber tip damage.Based on analysis results, the interaction between the user and device caused or contributed to the identified fiber tip damage and reported event.

Event Description

It was reported that at the beginning of the procedure, at around 80 joules, the glass tip was loose and the fiber tip was rotating.The laser ended up shooting through the cap.The physician used the fiber until it stopped working.The provided picture by the customer shows the fiber tip detached.The procedure was completed using transurethral resection of the prostate (turp) without patient complications.

Manufacturer Narrative

H10 additional mfr narrative: correction due to device analysis was updated.Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber did not confirm the reported detached fiber tip event.Visual analysis did identify that the fiber bevel edge was not aligned with the output window and the glass cap was protruding from the metal cap, indicating a glue failure.The media provided by the customer indicated the glass cap was still attached but sunk below the metal cap due to the glue failure.The metal cap exhibited severe charred debris adhesion, indicative of tissue contact.The identified metal cap tissue adhesion is likely to have contributed to continuous elevated temperatures to the output window.Continuously elevated temperature can lead to fiber damages, including glue failures.The interaction between the user and device caused or contributed to the observed fiber tip damage and reported event.According to the ifu, increased irrigation flow by means of a saline pressure bag (set to 250 mmhg to 300 mmhg) will further increase liquid cooling effect and may reduce fiber tip damage.Based on the analysis result, the tip of the fiber was found to be attached to the fiber.Instead, a glue failure was found.The information available indicated that the procedure was completed using transurethral resection of the prostate (turp) without patient complications.The information reasonably suggests that the identified glue failure is unlikely to cause patient harm if it was to reoccur.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 at the beginning of the procedure, at around 80 joules, the glass tip was loose and the fiber tip was rotating.The laser ended up shooting through the cap.The physician used the fiber until it stopped working.The provided picture by the customer shows the fiber tip detached.The procedure was completed using transurethral resection of the prostate (turp) without 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: 18103637
• MDR Text Key: 327888270
• Report Number: 2124215-2023-62484
• 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,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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