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

Model Number	0010-0622
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record confirmed that the device met all material, assembly and performance specifications prior to release.The returned fiber fiber did not exhibit signs of usage.Analysis revealed that the optical surface of the connector appeared burnt and melted.Information available indicated that no issues were encountered during testing of the fiber prior to use.Based on the information available and analysis of the device, the cause for the reported event cannot be determined.This report is for the same event as manufacturer report: 2937094-2018-00356.
Event or Problem Description
It was reported that the patient was under anesthesia for a microlaryngoscopy procedure.Upon starting the procedure, the fiber connector end part (*subject device) connecting to the console, burnt.A second fiber was utilized to continue the procedure; however, the same issue occurred.The physician aborted the procedure after the second fiber failed.The patient was reported to be okay.This is the 1st of 2 reports filed for this event.

• Brand Name: ENDOSTAT
• 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: 7387167
• Report Number: 2937094-2018-00355
• Device Sequence Number: 19096627
• Product Code: GEX
• UDI-Device Identifier: 00878953000107
• UDI-Public: 00878953000107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/14/2018

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: 09/28/2020
• Device Model Number: 0010-0622
• Device Catalogue Number: 0010-0622
• Device Lot Number: 740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1