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

Model Number 0010-0210

Device Problems Device Operates Differently Than Expected (2913); Issue With Displayed Error Message (2967); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  Injury  

Event Description

It was reported that during the procedure the "console had error codes 302.13, 515, 807 and 821".The case was completed with a "turp".Patient outcome: no patient injury was reported.

Manufacturer Narrative

System analysis/service repair on march 19, 2014: the ¿safety shutdown and unknown error code¿ was not confirmed.The system check noted roll call errors to the display.The display was replaced.The system was tested and verified to meet manufacturer¿s specifications.The top cover was returned to ams on march 25, 2014 and was sent to supplier.

Manufacturer Narrative

The top cover was returned to ams on (b)(6) 2014 and was sent to the supplier.Product evaluation: the top cover was evaluated by the supplier on (b)(6) 2014.The reported ¿errors 807, 821, 515 and 302.13¿ issues were not confirmed and no problem was found.The top cover passed the standard production test.Probable root cause: based on supplier fu report, the root cause was undetermined.

• Brand Name: GREENLIGHT XPS 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: 3704207
• MDR Text Key: 4263512
• Report Number: 2937094-2014-00221
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0010-0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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