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

Catalog Number 8065990836

Device Problems Unintended System Motion (1430); Firing Problem (4011)

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

Event Date 12/25/2019

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.The manufacturer internal reference number is: (b)(4).

Event Description

A company representative reported that the bed could not hold position.The surgeon had to control with joystick for ten seconds for the bed to lock.While lasering, the bed moved down by it's self when operating on the right eye.Focus became off ten percent of the way through the treatment.The surgeon stopped firing the laser.The surgeon had to reposition the bed and procedure was completed the same day.No patient harm was reported.New information was received.This issue was resolved successfully by calibrating again.The bed is refurbished.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company's acceptance criteria.According to follow-up information, this issue was resolved successfully by calibrating the function again.The root cause could not be determined conclusively.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: 9608670
• MDR Text Key: 194376686
• Report Number: 3003288808-2020-00035
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990836
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/25/2019
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR