MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) SUREFLEX FIBERS; POWERED LASER SURGICAL INSTRUMENT

Model Number	S-LLF200TG
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during ureteroscopy procedure; fiber was observed to be broken out from the package when opening during the case was noted.Additionally it was reported that the fiber was never used.The procedure was completed using second fiber.Patient outcome: no injury to the patient was reported.
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber (b)(4): 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 4.5 inches from distal tip; the length of second piece including the connector is 11 feet and 6 inches; the fiber exhibits no signs of melting at the location of fracture for first piece; the fiber was tested with hene laser fixture, aim beam is visible at the break.Probable root cause: based on the device analysis, the probable root cause of the failure is: excessive bending.

• Brand Name: SUREFLEX FIBERS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• MDR Report Key: 7217331
• Report Number: 2937094-2018-00090
• Device Sequence Number: 19086340
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 11/28/2019
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 648A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1