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

Model Number	S-LLF273TG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy procedure, the fiber "broke spontaneously in full intervention".It is unknown how was the procedure completed.There was no patient injury reported due to this event.No further information is available.
Additional Manufacturer Narrative
Analysis of the returned device showed the fiber overall length of 11 feet and 7 inches, connector included.The fiber distal tip is fractured.The fiber was tested with hene laser fixture, and the aim beam was visible at the distal tip.There was no signs of breakage along the length of the fiber and at the connector.Dark discoloration was noted near fiber tip within blue jacket.A review of the manufacturing records was performed and no issues that could have contributed to this event were found.The review of the manufacturing records did not identify any failure of the product to meet its material, assembly or performance specifications.Based on the device analysis, the probable cause of the failure cannot be determined.

• 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: 7758194
• Report Number: 2937094-2018-00848
• Device Sequence Number: 11082873
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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): 07/23/2018

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: 02/06/2021
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: 21690475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1