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

Catalog Number 8065990794

Device Problems Device Displays Incorrect Message (2591); Improper Device Output (2953)

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

Event Date 04/20/2016

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 device history records (dhr) for the device were reviewed.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A surgeon reported an energy failure during lasik treatment.Prior to treatment the laser was calibrated and passed the test process.During treatment the energy failure occurred and treatment was completed by repeatedly pressing the pedal to provide the energy.Additional information received; the energy error received was "not in the required range of 20%, continue by pressing the laser pedal.".

Manufacturer Narrative

Log file review showed that the target energy at the energy sensor and high voltage sensor was almost the same as previous energy checks.Thus, the conclusion is that the energy was acceptable, however the measurement at one sensor was too high.This is considered related to unstable reading of this sensor.The log file review confirmed this message showed up during a treatment as reported by the user.At the visit on site a field service engineer exchanged the sensor.The root cause could not be identified conclusively, because the sensor was not returned.(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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: eddie darton, md, jd ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 5675679
• MDR Text Key: 47125937
• Report Number: 3003288808-2016-00904
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Other Device ID Number: 00380659907944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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
• Patient Age: 23 YR