MAUDE Adverse Event Report: ELLEX MEDICAL PTY LTD ULTRA Q REFLEX; OPHTHALMIC LASER

Model Number	LQP3106-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Retinal Injury (2048)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As soon as ellex medical became aware of the incident, the calibration of the laser system and alignment of the optical paths was verified by ellex service through a paf (product acceptance fault record ).All the parameters in alignments check including offset in the paf are within the acceptance criteria which proves that the device is not at fault and is performing within the normal specifications.The general device aspects with respect to usability, instructions for use and the risk controls were evaluated: adequacy of device design: indications of parameters relevant to safety: anterior and posterior offset located on the laser head control knob are letter and colour coded.Accuracy of controls: offset range is well defined with the required tolerance.Adequacy of labelling: operator manual includes sufficient instructions, warnings, precautions for the safe use of the device and the labelling is considered adequate.Risk management: review indicated that the risk control measures (ra tango reflex-08 in attachment) are adequate and within the normal use risk levels are acceptable.Customer complaints: the device has been in use for 7 months with no untoward complaints.Patient monitoring: photocoagulated the lesion as a prophylactic measure since the physician could not see if there was a hole in the retina due to the hemorrhage.Patient is doing fine after photocoagulation.(b)(4).
Event or Problem Description
The event occured in (b)(6), doctor was treating a floater on a patient.Energy: started from 4mj, and increased the energy gradually since nothing was happening to the floater.Retinal bleeding happened at 8mj.
Additional Manufacturer Narrative
As soon as ellex medical became aware of the incident, the calibration of the laser system and alignment of the optical paths was verified by ellex service through a paf (product acceptance fault record ) attached.All the parameters in alignments check including offset in the paf are within the acceptance criteria which proves that the device is not at fault and is performing within the normal specifications.The general device aspects with respect to usability, instructions for use and the risk controls were evaluated.1) adequacy of device design : a) indications of parameters relevant to safety : anterior and posterior offset located on the laser head control knob are letter and colour coded.B) accuracy of controls : offset range is well defined with the required tolerance.2)adequacy of labelling : operator manual (included in attachment) includes sufficient instructions , warnings , precautions for the safe use of the device and the labelling is considered adequate.3) risk management : review indicated that the risk control measures ( ra tango reflex-08 in attachment) are adequate and within the normal use risk levels are acceptable.4) customer complaints : the device has been in use for 7 months with no untoward complaints.Patient monitoring : photocoagulated the lesion as a prophylactic measure since the physician could not see if there was a hole in the retina due to the hemorrhage.Patient is doing fine after photocoagulation.The user was recommended to complete laser training and the training certificate has been included.- attachment: [ellex_certificate_dr.Oishi.Zip].
Event or Problem Description
This is a follow up report.The event occured in japan, doctor was treating a floater on a patient.Energy: started from 4mj, and increased the energy gradually since nothing was happening to the floater.Retinal bleeding happened at 8mj.This report is made by ellex without prejudice and does not imply any admission of liability for the incident or its consequences.

• Brand Name: ULTRA Q REFLEX
• Common Device Name: OPHTHALMIC LASER
• Manufacturer (Section D): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, south australia 5095 ; AS 5095
• MDR Report Key: 8058542
• Report Number: 3013515803-2018-00011
• Device Sequence Number: 1910114
• Product Code: HQF
• UDI-Device Identifier: 09342395000038
• UDI-Public: (01)09342395000038(11)180410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LQP3106-U
• Device Catalogue Number: ULTRAQ_R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/12/2018
• Device Age: 7 MO
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/11/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR