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 02/15/2019

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

Event Description

A purchasing employee reported that energy was too high message appeared during a refractive treatment.Error message came up eight seconds into the treatment and the doctor could not continue.Upon follow up, the patient was seen later in afternoon and was doing well.The patient has been rescheduled to complete this procedure.

Manufacturer Narrative

During the visit on site the field service engineer (fse) replaced parts.The system meets specifications per service test procedure (stp).Logfile review for the day of event confirms a warning message displayed.The root cause cannot be identified conclusively.A possible root cause can be a defective board.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.The device history records (dhr) for the device was reviewed.The associated device was released based on company¿s acceptance criteria.Logfile review for the day of event confirmed the warning message 'internal energy too high! not in required range of twenty percent continue by pressing the laser pedal.So reported message and malfunction could be confirmed.During the visit on the site the field service engineer (fse) replaced the emr board.The system meets company¿s specifications per service test procedure (stp).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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 8403846
• MDR Text Key: 138357168
• Report Number: 3003288808-2019-00254
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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 Age: 30 YR