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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 06/01/2018
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.(b)(4).
 
Event Description
A facility representative reported loss of suction with a patient interface during flap creation.Additional information has been requested.
 
Manufacturer Narrative
Failure analysis shows the reported problem cannot be reproduced with the returned patient interface.No deviation of docking or other issues can be detected.The reported problem cannot be confirmed.No problem with the returned patient interface can be identified.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
With limited information the root cause could not be identified conclusively.The most possible root cause may be unnoticed movement of the patient during surgery, too much fluid on the eye or docking technique of the surgeon.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 Key8020091
MDR Text Key125645678
Report Number3003288808-2018-01736
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
Type of Report Initial,Followup,Followup
Report Date 10/04/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Initial Date Manufacturer Received 10/11/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received02/18/2019
09/20/2019
Supplement Dates FDA Received03/07/2019
10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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