MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC. SUREFLEX FIBERS; POWERED LASER SURGICAL INSTRUMENT

Model Number	S-LLF200TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the laser fiber snapped outside of the ureter scope while in use.The procedure was completed with another fiber.No patient or user clinical consequences were reported due to this event.
Additional Manufacturer Narrative
Analysis of the device revealed that the fiber was returned in two pieces.The fiber is broken and detached 6 feet and 6 inches from the connector.The second piece consisting of the distal tip measures 5 feet and 0.5 inches.The outer cladding appears stretched and stressed at break location.The fiber was tested with hene laser fixture, aim beam is visible at the break location.Based on the product investigation the complaint was confirmed, fiber break was observed.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure the laser fiber snapped outside of the ureter scope while in use.The procedure was completed with another fiber.No patient or user clinical consequences were reported due to this event.

• Brand Name: SUREFLEX FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC.; 3070 orchard drive; san jose CA 95134
• MDR Report Key: 8260861
• Report Number: 2937094-2018-60335
• Device Sequence Number: 2575371
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 05/01/2021
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 0022063167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1