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

Model Number	SLLF200TG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is for the same event as manufacturer report 2937094-2018-00743.
Event or Problem Description
It was reported that upon activation of the surgical fiber during a stone procedure, the fiber broke outside the scope near the physician.The output beam was reported to have hit the surgeon in the chest area of his lead gown but no perforation was noted.The fiber was replaced and the procedure continued using a second surgical fiber, which was reported to have broken upon activation inside of the scope.No patient or staff injury was reported.This event is for the second surgical fiber used.
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber (b)(4): the fiber returned in two pieces; the distal end of the glass fiber exhibits no signs of usage; the fiber is broken within the fiber blue outer sheath, and detached at 2 feet and 10.5 inches from distal tip; the length of second piece including the connector is 9 feet and 4 inches; the fiber was tested with hene laser fixture, aim beam is visible at the break.Probable root cause: based on the device analysis, the probable root cause of the failure is: handling damage.The probable root cause was determined based on excessive bending.This report is for the same event as manufacturer report 2937094-2018-00743.

• 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: 7660501
• Report Number: 2937094-2018-00744
• Device Sequence Number: 13795408
• Product Code: GEX
• UDI-Device Identifier: 00878953004822
• UDI-Public: 00878953004822
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/15/2018

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: 05/04/2020
• Device Model Number: SLLF200TG
• Device Catalogue Number: SLLF200TG
• Device Lot Number: S200719A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1