MAUDE Adverse Event Report: EXIMO MEDICAL LTD. AURYON LASER SYSTEM 100-120 VAC

Model Number EXM-2001-1100

Device Problems Melted (1385); Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to angiodynamics contracted repair center for servicing.A functional check of the unit determined the malfunction occurred due to the optics box.The spot was not overlapping and it was noticed that there was clipping on the tfp.The servicing technician adjusted mirror #2 to fix this, and then had to readjust mirrors #3-10 to make sure the beam was hitting center.The optics box was then baked at 50 degrees c for one hour and then checked for alignment the spot-on-spot was overlapping.The optics box was re-installed into laser and tested per procedure.The unit was determined to meet all acceptable criteria.A review of the device history records (service order system) was performed for the reported serial number exl141 for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.Labeling review: the user manual, which is supplied to the user with this unit states: safety precautions in any event of an internal fault in the laser system, turn off the laser system and call an eximo medical technician for further instructions.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Event Description

During a routine installation of an auryon laser unit at a medical facility, when testing of the unit, the unit failed due to the optics box melting the laser fibers inside the catheter.This caused the power levels to drop below specifications.The unit was unable to be repaired on-site, so it was removed from the facility and returned to the manufacturer for repair.There was no patient involvement,.

• Brand Name: AURYON LASER SYSTEM 100-120 VAC
• Type of Device: AURYON LASER SYSTEM 100-120 VAC
• Manufacturer (Section D): EXIMO MEDICAL LTD.; 3 pekeris street; glens falls, ny 12801, rehovot 76702 03; IS 7670203
• Manufacturer (Section G): EXIMO LTD.; 3 pekeris street; building 2, suite 270; science park, rehovot 76702 03; IS 7670203
• Manufacturer Contact: dr. yossi muncher ; 3 pekeris street; building 2, suite 270; science park, rehovot 76702-03 ; IS 7670203
• MDR Report Key: 11789903
• MDR Text Key: 250159755
• Report Number: 1319211-2021-10004
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EXM-2001-1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1