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	03/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a flexible ureteroscopy surgery with the destruction of a calculus by laser, the fiber broke after 5 minutes of grinding in the palm of the nurse who was holding the fiber with a compress.The sterile gloves as well as the blouse were perforated by the fiber and presence of a point of burning in the palm of hand of the nurse was noticed.There is no report of injury to the patient or how the case was completed.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Based on the product investigation, fiber break was confirmed.Analysis of the returned fiber revealed that the fiber distal end of the glass fiber exhibits no signs of usage but the blue outer sheath exhibits torn and stretching.The fiber is broken within the fiber blue outer sheath and detached at 8 feet from distal tip.The length of second piece including the connector is 4 feet and 2.5 inches.The fiber exhibits signs of melting at the location of fracture for first piece.The fiber was tested with hene laser fixture, aim beam is visible at the break.An evaluation 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 flexible ureteroscopy surgery with the destruction of a calculus by laser, the fiber broke after 5 minutes of grinding in the palm of the nurse who was holding the fiber with a compress.The sterile gloves as well as the blouse were perforated by the fiber and presence of a point of burning in the palm of hand of the nurse was noticed.There is no report of injury to the patient or how the case was completed.

• 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: 8522465
• Report Number: 2937094-2019-60489
• Device Sequence Number: 1884268
• 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,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 05/01/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 0022063166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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
• Patient Age: 67 YR