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); Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the glass cap was protruding from the metal cap, indicating glue failure.Analysis also identified a fiber body break at the input connector.The metal cap exhibited severe debris adhesion on the surface, indicative of heavy tissue contact during the procedure.The glass cap exhibited severe devitrification at the output window.Although analysis identified devitrification at the fiber tip, please note that fiber tip devitrification is normal degradation of the fiber which occurs through use of the fiber.The fiber was functionally tested with the hene (helium-neon) laser fixture.The testing conducted identified most of the output escapes from the fracture location.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.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

Event Description

It was reported that the fiber overheated, and the tip rotated within the metal cap.Analysis of the returned fiber indicated a break was found at the input connector.The procedure was completed with another device.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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17958149
• MDR Text Key: 326049536
• Report Number: 2124215-2023-57698
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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: 0030971005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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