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

Model Number	S-LLF200TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
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.The fiber has 0.5 inches of the fiber optic exposed at the proximal end, which was original inside the connector.The fiber proximal end exhibits severe burn marks and melting.The distal tip of the fiber exhibits is fractured.Black discoloration was noted near the proximal end within blue jacket.The ferrule is broken within the connector and the core fiber is loose.The fiber optic is broken within the connector.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
Analysis of the return device revealed that the distal tip of the fiber is fractured.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.; 3070 orchard drive; san jose CA 95134
• MDR Report Key: 8134251
• Report Number: 2937094-2018-60150
• Device Sequence Number: 13761560
• 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
• Report Date (Section B): 12/05/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1