MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC SUREFLEX FIBERS; POWERED LASER SURGICAL INSTRUMENT

Model Number	S-LLF200TG
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual event date of the complaint is unknown.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications prior to release.Analysis of the device found that the fiber was returned in two pieces.The fiber is broken and detached 28.5 inches from connector.The second piece measures 9 feet 10.5 inches.The outer cladding appears stretched and stressed at break location.There are no signs of melting at both break locations; the fiber was tested with hene laser fixture, aim beam is visible at the break location.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
Analysis of the device found that the fiber was broken and detached.There was no patient outcome information available.

• 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: 8489415
• Report Number: 2937094-2019-60458
• Device Sequence Number: 16635531
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K140679
• 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): 04/05/2019

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: 09/21/2020
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: S200739A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/05/2019
• Patient Sequence Number: 1