MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUREFLEX 273; POWERED LASER SURGICAL INSTRUMENT

Model Number	S-LLF273TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during lithotripsy procedure, the fiber broke inside the patient.It was noted that a piece was stuck in the patient and that the fiber break caused damage to scope used as well.No further information provided on procedure outcome.There were no patient complications.
Additional Manufacturer Narrative
The device has not been returned to bsc for evaluation; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that, during lithotripsy procedure, the fiber broke inside the patient.It was noted that a piece was stuck in the patient and that the fiber break caused damage to scope used as well.No further information provided on the procedure outcome.There were no patient complications.

• Brand Name: SUREFLEX 273
• 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; 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: 21777875
• Report Number: 2124215-2025-20797
• Device Sequence Number: 8593484
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: (01)00878953004839(17)270221(10)33475878
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0033475878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown