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

Model Number 0010R0070

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913); Issue With Displayed Error Message (2967); Output Problem (3005)

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

Event Date 01/06/2016

Event Type  malfunction  

Event Description

It was reported that during a procedure error 172 was observed four separate times.The first three times the laser shut down the laser was able to be restarted however when the laser shut down the fourth time the laser was not able to be restarted.The procedure as complete with an unknown alternative method.Patient outcome "ok" reported.No injury was reported.

Manufacturer Narrative

System analysis/service repair on (b)(6) 2016: error 172 and 111 were verified and determined to be the result of a faulty resonator.The resonator was replaced.The system was tested and verified to specification.

Manufacturer Narrative

System analysis/service repair was performed on january 08, 2016.The resonator s/n (b)(4) was returned to the manufacturer on january 13, 2016.

Manufacturer Narrative

System analysis/service repair was performed on january 08, 2016.The resonator s/n (b)(4) was returned to the manufacturer on january 13, 2016.Product evaluation: the resonator s/n (b)(4) was evaluated on february 18, 2016.The evaluation noted no damage to packaging and no external damage to the resonator; low diode voltage was noted; only 6 bars light up and all optical parts were noted to be fine.The diode and desiccant were replaced.The resonator power was re-peaked and a new test report was completed.Probable root cause: based on the fa report, the root cause was determined to be diode assembly.

Manufacturer Narrative

• Brand Name: GREENLIGHT HPS LASER SYSTEM
• 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: jennifer mascioli-tudor ; 3070 orchard drive; san jose, CA 95134 ; 4084563300
• MDR Report Key: 5350077
• MDR Text Key: 35217290
• Report Number: 2937094-2016-00019
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0010R0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other