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

Model Number	S-LLF273TG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the surgical fiber broke inside the patient during the procedure.There was no clinical consequence to the patient reported as a result of this event.The physician attempted to use a different model of the device but found that it was broken while removing it from the packaging.The procedure was completed utilizing a third fiber without issue.This event is for the first surgical fiber used.
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber (b)(4): the fiber returned in two pieces; the distal end of the glass fiber exhibits no signs of usage; the fiber is broken within the fiber blue outer sheath, and detached at 6 feet and 11 inches from distal tip; the length of second piece including the connector is 5 feet and 2 inches; black discoloration was noted at near break location and fiber tip within blue jacket; the fiber exhibits no signs of melting at the location of fracture for first piece; 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: 7106632
• Report Number: 2937094-2017-01081
• Device Sequence Number: 1895611
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2017

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: 01/03/2020
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 701A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 02/12/2018; 04/03/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/25/2018; 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1