MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. 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	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the exact date of this event is not known.The total length of the fiber is 11 feet 7 inches, connector not included in over-all length.The connector is detached and returned.The fiber proximal end exhibits severe burns and melting.The distal tip of the fiber exhibits no signs of usage.Black discoloration was noted near proximal end within blue jacket.The fiber was tested with hene laser fixture, aim beam is visible at break location.Cannot determine when and how fiber was detached from product after final inspection.
Event or Problem Description
It was reported that during a surgical procedure the "lma" was found to be detached.The fiber was not used.It was not reported how the procedure was completed.There was no patient outcome information reported.

• 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: 8120318
• Report Number: 2937094-2018-60138
• Device Sequence Number: 1656937
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 03/06/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0021813636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1