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

Model Number	S-LLF200TG
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
Analysis of the returned device revealed that the fiber was returned in two pieces.The fiber distal tip is fractured.The fiber is broken within the fiber blue outer sheath, and detached at 9.5 inches from distal tip.The length of the second piece including the connector is 10 feet and 9.5 inches.The fiber exhibits signs of melting at the location of fracture for first piece.The fiber was tested with hene laser fixture, and the aim beam is visible at the break.Based on the device analysis, the probable cause of the failure is handling damage.An evaluation conclusion code of cause traced to user was assigned to this investigation.
Event or Problem Description
Analysis of the return device revealed that the fiber is broken within the fiber blue outer sheath, a fracture on the distal tip of the fiber, and a detachment of the fiber 9.5 inches from the distal tip.There were no patient complications reported due to this event.

• 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: 7728405
• Report Number: 2937094-2018-00811
• Device Sequence Number: 19183702
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 01/09/2020
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 704B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1