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

Model Number 0010-2090

Device Problems Melted (1385); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis of the returned device revealed that the fiber cap exhibits signs of melting that formed a hole from the surface to the bevel edge.An unknown white substance was noted inside the distal end of the fiber cap.The glass cap exhibits devitrification at the output window and detritus around the output area.The outer flow tubing open end exhibits minor scratch marks.No other anomalies were noted.Based on device analysis, the potential for forward firing may exist.The probable cause of the failure is operational context.The cause was determined based on heat accumulation.Cap wear was accelerated due to anatomical/procedural factors (tissue contact and technique) encountered during the procedure which would limit the performance of the fiber.The identified issues noted above may activate the fiberlife function which would modulate the power showing a pulsing beam or system would be placed into standby mode.

Event Description

Analysis of the return device revealed a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge.Based on the device analysis, the potential for forward firing may exist.There were no patient complications reported due to this event.

• Brand Name: GREENLIGHT MOXY FIBER OPTIC
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• Manufacturer Contact: alyson harris ; 3070 orchard drive; san jose, CA 95134 ; 4084563300
• MDR Report Key: 7950018
• MDR Text Key: 123369402
• Report Number: 2937094-2018-01058
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: 00878953004709
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 21387802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1