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U.S. Department of Health and Human Services

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

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WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Catalog Number 8065990941
Device Problem Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
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
An optometrist reported that suction was lost 50 percent of the way through a procedure.The patient did not move.The event occurred after the laser was fired.The procedure was completed.
 
Manufacturer Narrative
A logfile review of the day of the treatment showed three system tests for vacuum, energy and ablation were executed by the user without any problems.The reported treatment could be identified in the logfile.The treatment was aborted after the warning message.The message indicated that the user released laser pedals and pressed the right footswitch to turn off the vacuum.The user restarted the treatment and performed the treatment successfully on that day.No technical root cause is detectable.The root cause is user handling.The manufacturer internal reference number is: (b)(4).
 
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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 Key7955468
MDR Text Key123501702
Report Number3003288808-2018-01655
Device Sequence Number1
Product Code GEX
Combination Product (y/n)N
PMA/PMN Number
K101006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/31/2019
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 Number8065990941
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/17/2018
Initial Date FDA Received10/11/2018
Supplement Dates Manufacturer Received01/24/2019
Supplement Dates FDA Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age19 YR
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