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

Model Number	S-LLF200TG
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure after plugging the fiber into the console, the connector overheated, began smoking, and once removed fell off.A second fiber was connected to the console and the connector overheated.The fiber was removed and a third fiber was plugged into the console.The case was completed without injury to the patient or user.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed that the total length of the fiber is 12 feet 0.5 inches, connector not included in over-all length.The connector is detached and returned.Portion of connector internal black tubing is connected to the fiber.The fiber proximal end exhibits melting.The distal tip of the fiber exhibits no signs of usage.Black discoloration was noted near the distal tip and proximal end within blue jacket.The fiber optic broke in connector based on the fiber imaging.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure after plugging the fiber into the console, the connector overheated, began smoking, and once removed fell off.A second fiber was connected to the console and the connector overheated.The fiber was removed and a third fiber was plugged into the console.The case was completed without injury to the patient or user.

• 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: 7945497
• Report Number: 2937094-2018-60026
• Device Sequence Number: 19025114
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 04/03/2021
• Device Model Number: S-LLF200TG
• Device Catalogue Number: S-LLF200TG
• Device Lot Number: 21917858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1