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

Model Number	S-LLF273TG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for the same event as manufacturer report 2937094-2018-00738.
Event or Problem Description
It was reported that while using the surgical fiber during a stone procedure, the fiber broke outside the scope and the output beam hit the surgeon in the chest.There was no damage to the surgeon's gown scrubs.The fiber was replaced and the procedure continued until the fiber again broke outside the scope, close to the surgeon.The output beam was reported to hit the surgeon on sleeve, leaving a small hole in his gown.The surgeon later reported bruising to the mobile provider during a follow up but has provided no additional information.There was no patient injury reported.This event is for the first surgical fiber used.

• 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: 7659840
• Report Number: 2937094-2018-00739
• Device Sequence Number: 2355086
• Product Code: GEX
• UDI-Device Identifier: 00878953004839
• UDI-Public: 00878953004839
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: S-LLF273TG
• Device Catalogue Number: S-LLF273TG
• Device Lot Number: S273741A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/03/2018
• 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