MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 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	07/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber broke spontaneously in the flexible ureteroscope in such a way that there was no output beam.No information was provided as to how the procedure was completed.There was no patient injury due to this event.

• 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: 7760089
• Report Number: 2937094-2018-00852
• Device Sequence Number: 1757476
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• 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,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 08/17/2020
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 734A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1