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	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event was not reported therefore the bsc aware was chosen for the date of the event.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the fiber is broken within the fiber blue jacket and bent at 5 mm from distal tip.The fiber exhibits no signs of usage.Black discoloration was noted at near break location within blue jacket.The total length of the fiber is 12 feet and 2.25 inches, connector included in over-all length.The fiber was tested with hene laser fixture, aim beam is visible at the break.Based on device analysis, the complaint was confirmed.Fiber broke and bent.The identified issues noted above may have been caused by excessive bending during the procedure.An evaluation conclusion code of unintended user error caused or contributed to event was assigned to this investigation.
Event or Problem Description
Analysis of the device found that the fiber is broken within the fiber blue jacket and bent at 5 mm from distal tip.There was no patient injury 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: 8501772
• Report Number: 2937094-2019-60467
• Device Sequence Number: 2798062
• 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,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 03/13/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0021849929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1