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

Model Number	S-LLF273TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure the fiber broke in two.The operator's right arm was burned and a bandage with biafine was administered in response to the event.No harm to the patient reported.
Additional Manufacturer Narrative
Analysis of the returned device revealed that 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 5 feet and 2 inches from distal tip.The length of second piece including the connector is 7 feet and 0.5 inches.The fiber was tested with hene laser fixture, aim beam is visible at the break.Based on the review of the analysis results the cause for the observed fiber damage is excessive bending of the fiber; therefore, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure the fiber broke in two.The operator's right arm was burned and a bandage with biafine was administered in response to the event.No special treatment or medical intervention occurred to treat the burn.The case was completed with no harm to the patient.

• 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: 8020833
• Report Number: 2937094-2018-60070
• Device Sequence Number: 1755681
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 21576970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other