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

Model Number	S-LLF200TG
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using two sureflex fibers during a procedure, the fiber ends broke off.No other information was provided.There was no injury reported.This event is for the second surgical fiber used.

• 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: 7131753
• Report Number: 2937094-2017-01114
• Device Sequence Number: 2144504
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 01/19/2020
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 704B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1