MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS ARN GREENLIGHT MOXY FIBER LASER; GREEN LIGHT LASER MOXY FIBER

Model Number 10-2400

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2014

Event Type  Injury  

Event Description

Photo selective vaporization of prostate concluded on patient.Laser fiber used for 31 minutes 19 seconds.299653 joules used.Fiber removed from patient per (b)(6).Fiber not inspected after use.Patient urinated out tip of laser fiber 17 days post op.Diagnosis or reason for use: #1 bph.#2 urinary retention.

• Brand Name: ARN GREENLIGHT MOXY FIBER LASER
• Type of Device: GREEN LIGHT LASER MOXY FIBER
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 3070 orchand dr.; san jose CA 95134 201
• MDR Report Key: 4888113
• MDR Text Key: 18032334
• Report Number: MW5043441
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

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 Model Number: 10-2400
• Device Lot Number: 10-2400-460A-1683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 100