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); Power Problem (3010); Firing Problem (4011)

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

Event Date 02/17/2024

Event Type  malfunction  

Manufacturer Narrative

There was no device available for analysis; however, the reported complaint was confirmed by the media provided by the costumer.Media also showed that the fiber was burned.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, a labeling review was performed and ifu includes specific warnings/instructions related to "fiber beam blinking/flashing/pulsing, fiber cap/tip fiber rotates within metal cap, fiber cap/tip break, fiber stopped working".There is no indication that the device was not used in accordance with the ifu.Based on the information provided, all compiled information on this investigation determines that the most probable cause is unintended use error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.

Event Description

It was reported that during a photoselective vaporization of the prostate (pvp) procedure to treat benign prostatic hyperplasia (bph), the fiber beam began to intermittently flicker, and the fiber tip was rotating inside the metal cap of the fiber.Upon removing the fiber, the glass cap had broken off.The fiber had stopped working.The fiber was checked, and was no longer working, so another fiber was used to complete the procedure.No patient complications were reported.

• 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: 18865953
• MDR Text Key: 337218367
• Report Number: 2124215-2024-14195
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 0031089644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 53 YR
• Patient Sex: Male