MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Model Number	6464
Medical Device Problem Codes	Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the device found the fiber was received in two pieces.The glass tip was in good/unused condition.During functional testing light from the subminiature a connector (sma) connector was bright and round, indicating that there was no fracture within the connector.It is possible that the breakage occurred due to procedural handling after the customer tried to use the fiber.Despite the fiber being broken, it had not been used.The console read that the fiber was ready for usage, there was no error message.Based on analysis, the reported allegation was not confirmed, since during test the fiber was read for use.However, visual examination identified that the fiber was broken in two pieces.The glass tip was in good/unused condition.It is possible that the breakage occurred due to procedural handling after the customer tried to use the fiber.
Event or Problem Description
It was reported that, during a lithotripsy procedure, the console issued an error when the fiber was connected.The procedure was completed with another device without patient complications.Device analysis found that the fiber was broken.
Event or Problem Description
It was reported that, during a lithotripsy procedure, the console issued an error when the fiber was connected.The procedure was completed with another device without patient complications.Device analysis found that the fiber was broken.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the device found the fiber was received in two pieces.The glass tip was in good/unused condition.During functional testing light from the subminiature a connector (sma) connector was bright and round, indicating that there was no fracture within the connector.It is possible that the breakage occurred due to procedural handling after the customer tried to use the fiber.Despite the fiber being broken, it had not been used.The console read that the fiber was ready for usage, there was no error message.Based on analysis, the reported allegation was not confirmed, since during test the fiber was read for use.However, visual examination identified that the fiber was broken in two pieces.The glass tip was in good/unused condition.It is possible that the breakage occurred due to procedural handling after the customer tried to use the fiber.

• Brand Name: LIGHTTRAIL SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18248534
• Report Number: 2124215-2023-66491
• Device Sequence Number: 15251734
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: 08714729939801
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 6464
• Device Catalogue Number: 6464
• Device Lot Number: 0027619737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown