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

Model Number	S-LLF200TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis.A device history record (dhr) review confirmed that the devices met all material, assembly and performance specifications.Based on a thorough review of the reported complaint, an evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the fiber was broken reaching the lower pole stone in the kidney.The method used to complete the procedure and patient outcome were not reported.
Event or Problem Description
It was reported that the fiber was broken reaching the lower pole stone in the kidney.The method used to complete the procedure and patient outcome were not reported.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device identified that the fiber was broken within the fiber blue outer sheath.Black discoloration was noted near the break location within the blue jacket.The fiber exhibits signs of melting at fracture location.The distal end exhibited signs of usage and fracture.Based on the investigation results the probable cause of the fractures could not be determined so an evaluation cause code of cause not established was assigned.

• Brand Name: SUREFLEX FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9759400
• Report Number: 2937094-2020-00189
• Device Sequence Number: 2496663
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 10/18/2021
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 0022812964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1