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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENIS LTD LUMENIS SLIMLINE SIS REUSABLE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT
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LUMENIS LTD LUMENIS SLIMLINE SIS REUSABLE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number 840-923
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2024
Event Type  malfunction  
Event Description
It was reported that during retrograde intrarenal surgery procedure, the fiber broke in two after it was sterilized twice.Due to this, the procedure was completed using another device.There were no patient complications.
 
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Brand Name
LUMENIS SLIMLINE SIS REUSABLE LASER FIBER
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
LUMENIS LTD
hakidma 6
yokneam 20692 04
IS  2069204
Manufacturer (Section G)
LUMENIS LTD.
hakidma st 6
yokneam 20692 04
IS   2069204
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key19159959
MDR Text Key341467699
Report Number2124215-2024-24380
Device Sequence Number1
Product Code GEX
UDI-Device Identifier07290109140223
UDI-Public07290109140223
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K170121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/22/2024
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 Number840-923
Device Catalogue Number840-923
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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