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 01/30/2024

Event Type  malfunction  

Event Description

It was reported that during a photo selective vaporization of the prostate procedure, the fiber broke when it was used at only half its capacity.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.

Manufacturer Narrative

With all the available information, boston scientific concludes that the fiber did not present any breakages.Analysis did identify that the glass cap of the fiber was more protrude that normal, indicative of a glue failure; therefore, the event reported was not confirmed.The fiber was tested with hene (helium-neon) laser fixture and there were no sings observed for a break at the length of 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.The identified level of debris adhesion on the metal cap surface probably contributed to elevated temperature near the laser beam output window leading to the glue failure.The increase in temperature near the laser beam output window can be caused by tissue adhesion from constant and heavy tissue contact and/or a decrease in saline cooling flow.Continuously elevated temperature can lead to fiber damage, like the glue failure observed.According to the instructions for use (ifu), increasing the irrigation flow through a pressurized saline bag (set to 250 mmhg 300 mmhg) will further increase the liquid cooling effect and may reduce fiber tip damage.Although analysis also identified a severe level detritus on the fiber.The information reasonably suggest that the identified glue failure is unlikely to cause patient harm if it were 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 during a photo selective vaporization of the prostate procedure, the fiber broke when it was used at only half its capacity.The information about the patient and procedure outcome are unknown.Boston scientific has been unable to obtain additional information regarding the patient and procedure outcome to date, despite good faith efforts.

• 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: 18785046
• MDR Text Key: 336305101
• Report Number: 2124215-2024-11433
• 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: 04/24/2024

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: 0031089653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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