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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 EASYPACK PATIENT INTERFACE; POWERED LASER SURGICAL INSTRUMENT
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WAVELIGHT GMBH WAVELIGHT FS200 EASYPACK PATIENT INTERFACE; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number 1515
Device Problem Suction Problem (2170)
Patient Problem Insufficient Information (4580)
Event Date 07/17/2020
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 certified ophthalmic assistant reported suction was lost.There are multiple related reports for this patient.This report addresses one patient interface on (b)(6) 2020 and another manufacturer report will be filed for the additional patient interface used.
 
Manufacturer Narrative
A review of the device history record (dhr) was traceable to the reported serial number indicating that the product was processed and released according to the product¿s acceptance criteria.The root cause could not be identified conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
WAVELIGHT FS200 EASYPACK PATIENT INTERFACE
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 91058
GM  91058
MDR Report Key10610815
MDR Text Key209556667
Report Number3003288808-2020-00591
Device Sequence Number1
Product Code GEX
Combination Product (y/n)N
PMA/PMN Number
K190392
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1515
Device Catalogue Number8065998299
Device Lot NumberL05221
Was Device Available for Evaluation? No
Date Manufacturer Received10/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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