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

Model Number	S-LLF273TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy procedure, the surgical fiber was noted to have broken inside of the scope, upstream of the site of intervention, ¿causing a burning pain in the surgeon¿s hand¿.No subsequent treatment or injury of the surgeon was reported.The surgical fiber and scope were exchanged resulting in a slight delay in completing the procedure.No harm to the patient reported.
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber (b)(4): the distal end of the glass fiber exhibits signs of usage; the fiber is broken within the fiber blue outer sheath, and detached at 2 feet and 10.5 inches from distal tip; the length of second piece including the connector is 9 feet and 4 inches; the fiber exhibits signs of slight melting at the locations of fracture; 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: 7109502
• Report Number: 2937094-2017-01083
• Device Sequence Number: 1311030
• Product Code: GEX
• UDI-Device Identifier: 00878953000152
• UDI-Public: 00878953000152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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: 07/12/2020
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 729A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1