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

Catalog Number 8065990941

Device Problem Suction Problem (2170)

Patient Problem Vascular Dissection (3160)

Event Date 09/13/2018

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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.(b)(4).

Event Description

A physician reported when performing a lasik procedure on a patient's left eye, suction was interrupted involuntarily in the middle of the procedure.This left only the middle of the corneal bed dissected.The beginning of the side cut was not reached.Surgery was suspended and physician is waiting to evaluate.Upon follow up, the surgery was aborted.The patient had an incomplete flap.Vision was reported to be the same as the day before the procedure.Only one part of the procedure was performed.Therefore, there is a need to wait to plan for a new surgery.

Manufacturer Narrative

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

Event Description

Additional information was received.Surgery has been completed satisfactorily on the eye that loss suction in the middle of the treatment.A new deeper flap was programmed and the hinge was positioned in a different place from the first surgery.

Manufacturer Narrative

Risk is considered to be reduced as far as possible.Reviewing risk analysis concludes that no serious deterioration in state of health or death can be caused by the reported event.To the current knowledge and based on the risk analysis, there is no indication for a product problem which (might have) caused or contributed to a serious deterioration in state of health or death.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.The risk is considered to be reduced as far as possible.Risk analysis was reviewed and it can be concluded that no serious deterioration in state of health or death could be caused by the reported event.To the current knowledge and based on the risk analysis, there is no indication for a product problem which (might have) caused or contributed to a serious deterioration in state of health or death.A logfile review for the whole day was performed.The review of logfile showed at system startup, no error messages or parameter deviations could be seen from the log file which points to the problem described.The three system test for vacuum, energy and ablation was executed by the user without any problems.Logfile review showed one treatment aborted after the warning message during bed cut.The message indicated that the user released laser pedals and pressed the right footswitch to turn off the vacuum.The user did not restart the treatment.The root cause could be determined as user handling.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: 7942495
• MDR Text Key: 123252048
• Report Number: 3003288808-2018-01637
• 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,Followup
• Report Date: 02/21/2019

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: 8065990941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 11/09/2018; 01/27/2019; 02/15/2019
• Supplement Dates FDA Received: 11/30/2018; 01/31/2019; 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1