Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 200 D\F\L; POWERED LASER SURGICAL INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LUMENIS LTD LUMENIS MOSES 200 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 03/06/2024
Event Type  malfunction  
Event Description
It was reported that prior to the procedure, when the package was opened the fiber tip looked fractured at the tip.It looked like a hairbrush and the glass looked all broken.The procedure was completed successfully with the same fiber.No patient complications were reported.
 
Event Description
It was reported that prior to the procedure, when the package was opened the fiber tip looked fractured at the tip.It looked like a hairbrush and the glass looked all broken.The procedure was completed successfully with the same fiber.No patient complications were reported.
 
Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Analysis of the returned fiber did not confirm the reported fractured/broken fiber tip event.Visual analysis did not identify any defect.The fiber was received in one piece.The fiber tip was in good condition, the ball of the tip was still present, the fiber tip was not broken, and the fiber jacket had signs of stripping.The aiming beam was bright and round, exiting the connector face.The console read that the fiber was used, and read: error 67, fiber expired.According to the device instruction for use (ifu), the ifu states: caution: careful handling of the fiber during setup is important to prevent fiber damage.Fiber damage may impact fiber performance.Inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.For the moses 200 d/f/l lp fiber, verify that the ball tip is complete and not damaged.Hold the fiber tip to a non-reflective surface and ensure that a circular green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement insert the fiber into the stripper so that the tip extends two centimeters past the blades.Squeeze the stripper handles with one hand while gripping the fiber with the other hand.Rotate the stripper 90 degree, and quickly pull the fiber from the strippers.Based on the analysis result and information available, there was no fiber tip break found during analysis.The information reasonably suggests that a fiber with no defect is unlikely to cause patient harm.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LUMENIS MOSES 200 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
hakidma st 6
mittweida 09468
GM   09468
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18992629
MDR Text Key339103146
Report Number2124215-2024-18751
Device Sequence Number1
Product Code GEX
UDI-Device Identifier07290109143170
UDI-Public07290109143170
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 Nurse
Type of Report Initial,Followup
Report Date 05/17/2024
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 Number0003262310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received03/28/2024
Supplement Dates Manufacturer Received05/13/2024
Supplement Dates FDA Received05/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-