MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. GREENLIGHT HPS BPH FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-2090

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed that the fiber cap exhibits signs of melting which formed a hole from the surface to the bevel edge.There is some white unknown substance noted inside the distal end of fiber cap.The glass cap exhibits devitrification at the output area, and detritus adhesion around output area.The heat shrink tubing exhibits minor scratch marks.Based on device analysis, the potential for forward firing may exist.It is probable that 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.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

Analysis of the device found the fiber cap exhibits signs of melting which formed a hole from the surface to the bevel edge.Based on device analysis, the potential for forward firing may exist.There was no patient injury reported.

• Brand Name: GREENLIGHT HPS BPH FIBER OPTIC
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 3070 orchard drive; san jose CA 95134
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 3070 orchard drive,; san jose CA 95134
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 8190560
• MDR Text Key: 131305338
• Report Number: 2937094-2018-60263
• 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: K062719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 0021387802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 11/30/2018
• 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