MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 8065990941

Device Problem Suction Problem (2170)

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

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.The associated device was released based on company's acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to treatment date.Review of the logfiles for the day of treatment showed no error or warning that could contribute to the reported event.During start-up of the system, the vacuum check, the energy check and the ablation tests were performed without error.All treatments on that day were completed successfully.The logfile showed the user operated the surgery with the recommended setting.No relevant deviation between planned and performed energy was detectable for the treatment.The vacuum was good and stable.No abnormality regarding z-offset setting could be identified.No technical root cause could be identified during logfile review for the reported treatment day.No technical root cause was identified as the product was found to be within specifications.There is no indication for a product problem which (might have) caused or contributed to the reported event.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported having problems with suction on two patients.Suction occurs but eye moves around more than usual irregular flap layers were created and there were problems when opening the flaps.Thickness of flaps were not programmed.Surgeon is not comfortable with the equipment.Upon follow up, the doctor feels that the diameters of the flaps are not nine millimeters as programmed and will be measuring the thickness by optical coherence tomography.The doctor feels they are irregular.It was noted that the doctor had a problem when docking this patient, the doctor felt that vacuum was falsely created and that the suction was not too powerful.It took the doctor a long time to open the flap and the layers were totally irregular.The doctor continues to monitor the patient.Upon follow up, the patient is regular now.There are multiple related reports for this patient.This report addresses the patient two's left eye and other manufacturer reports will be filed.

Manufacturer Narrative

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

Manufacturer Narrative

During an onsite visit, the field service engineer (fse) could not replicate the reported issue.The fse replaced the applications interface as preventive measure.Applications interface received and failure investigation was performed: visual and functional inspection of the application interface shows no malfunction.No malfunction could be confirmed.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 8422612
• MDR Text Key: 139069989
• Report Number: 3003288808-2019-00284
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1