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

Model Number	S-LLF273TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the returned fiber revealed the fiber returned in two pieces.The distal end of the glass fiber exhibits no signs of usage.The fiber is broken within the fiber blue outer sheath, and detached at 9 feet and 3.5 inches from distal tip.The length of second piece including the connector is 2 feet and 11 inches.The fiber was tested with hene laser fixture, aim beam is visible at the break.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the fiber was noticed to be broken inside of the scope during a urs procedure to remove a stone in the kidney.The device was removed and the procedure was completed utilizing another of the same device.The patient was reported to be stable.

• Brand Name: SUREFLEX FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 150 baytech drive; san jose CA 95134
• MDR Report Key: 9219430
• Report Number: 2937094-2019-61392
• Device Sequence Number: 2685057
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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: 04/18/2022
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0023665858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1