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 Code Available (3191)

Event Date 02/01/2019

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.(b)(4).

Event Description

A center director reported that the laser would not start up again while performing a procedure on a patient's left eye.Flap was created and then was lifted.The patient moved a bit so the doctor took his foot off the pedal and then the laser would not restart again to finish treating the patient.Laser was rebooted which caused a delay.Surgery was resumed once the reboot was completed.However, the patient had to sit longer because she pupil shape needed to be reset a bit due to the delay while waiting for the laser to reboot.

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: 8360199
• MDR Text Key: 137123148
• Report Number: 3003288808-2019-00213
• 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