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

Model Number	S-LLF273TG
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is for the same event as manufacturer report number 2937094-2018-00061.
Event or Problem Description
It was reported that during a procedure, two fibers were broken 2cm from the exit of the operating canal.The method used to complete the procedure was not reported.No additional event information was provided.There was no injury reported.This event is for the first surgical fiber used.
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber (b)(4): the total length of the fiber is 11 feet and 2.5 inches, connector included in over-all length; the fiber distal tip is fractured; the fiber was tested with hene laser fixture, aim beam is visible at the distal tip; dark discoloration was noted near fiber tip within blue jacket there is no signs of breakage along the length of the fiber and at the connector.Probable root cause: based on the device analysis, the probable root cause of the failure could not be established based on the results of the investigation.Additional information: review of lot 736a dhr did not indicate any failures upon final inspection.

• 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: 7208660
• Report Number: 2937094-2018-00060
• Device Sequence Number: 13698154
• 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: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: 08/31/2020
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 736A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 01/20/2018
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1