MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990794

Device Problem Output above Specifications (1432)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.(b)(4).

Event Description

A facility representative reported receiving an energy too high message during surgery.The treatment was not completed.Additional information was requested.

Manufacturer Narrative

A logfile review for the day of treatment shows an energy message occurred during energy check and fluence test at the end of the surgery day and the message repeated many times during calibration check.No surgery was performed after these warning messages that day.All surgeries before these info message were completed successfully without problem.During technical onsite visit the field service engineer (fse) found n2 generator was not working correctly and replaced the n2 generator.The fse completed service installation record per company specifications.Root cause for the faulty n2 generator could be performed without sample.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 8079152
• MDR Text Key: 127553826
• Report Number: 3003288808-2018-01837
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1