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

Catalog Number 8065990713

Device Problem Failure to Deliver Energy (1211)

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

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.Device history record (dhr) for the device was reviewed.The associated device was released based on company's acceptance criteria.The manufacturer internal reference number is: (b)(4).

Event Description

A center director reported that there has been 3 episodes over the past two days where the doctor took his foot off the treatment pedal.The patient moved a bit and a warning chime appeared on the screen.The technician usually clears the warning and upon reapplying the right pedal and then pressing the left, the laser usually continues to come on.At this point, the laser would not continue with the remainder of the treatment despite the eyetracker being at 100%.The only way to get the remainder of the treatment done was to reboot the laser.

Manufacturer Narrative

The system history shows that the laser was verified successfully prior date of treatment.Logfile review shows there was a message on the screen.This message can occur when the pedal switches have a different reference position, caused by the pedal not being pressed firmly straight down by the customer.After this message the customer tries to do a center test, however, review shows several times the information ¿treatment stopped¿ by finishing the session and cancelling the treatment.There is no other indication for the reported event.The root cause can be determined as an inappropriate handling of the foot switch (laser pedal).Pushing the foot switch (laser pedal) in hesitant, slow or too fast manner will lead to this message thus to interruption of the treatment.The device is working as intended.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: 8360200
• MDR Text Key: 137127904
• Report Number: 3003288808-2019-00215
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1