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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 365 D\F\L; POWERED LASER SURGICAL INSTRUMENT
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LUMENIS LTD LUMENIS MOSES 365 D\F\L; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number 1912-10
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Event Description
It was reported that the fiber split when being used for a stone procedure.The procedure was completed using another fiber without patient complications.
 
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Brand Name
LUMENIS MOSES 365 D\F\L
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
LUMENIS LTD
hakidma 6
yokneam 20692 04
IS  2069204
Manufacturer (Section G)
ADVANCED FIBER TOOLS GMBH
bornheimer str 4
mittweida 09468
GM   09468
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key19113207
MDR Text Key340252501
Report Number2124215-2024-22575
Device Sequence Number1
Product Code GEX
UDI-Device Identifier07290109143408
UDI-Public07290109143408
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/15/2024
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 Model Number1912-10
Device Catalogue Number1912-10
Device Lot Number0002822308
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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