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	01/01/2018
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 checks 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 (included in attachment) 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 9 months from the date of installation; no other untoward incidents related to device use were reported apart from this event.The service rep did confirm that the doctor acknowledged that he had not checked to confirm his proper prescription on the two oculars and therefore the laser and the field of view were not coincidental.The doctor was using "0" on the oculars when it should have been "-2".The field service technician reviewed the ocular settings with the doctor (s).The operator error caused the laser to hit posteriorly to tissue where the doctor thought he was in focus.The doctor and his practice are not willing to share any patient information after multiple requests.E2018008.
Event or Problem Description
The event occured in usa, (b)(6).During treatment for posterior membranectomy, the doctor hit the patient's retina , causing a small contusion.Possible user error.

• 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: 7322433
• Report Number: 3013515803-2018-00003
• Device Sequence Number: 1605462
• Product Code: HQF
• UDI-Device Identifier: 09342395000427
• UDI-Public: (01)09342395000427(11)161013
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K992824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2018
• Device Age: 18 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1