MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for TANGO R LT5106-T manufactured by Ellex Medical Pty Ltd.
[183371855]
It was a new system manufactured in jan'20 and installed in february, the doctor has been using the laser since the event with no other complications on additional patients - he believes the injury was caused by patient movement only.
Patient Sequence No: 1, Text Type: N, H10
[183371856]
Doctor, using a tango-reflex for posterior mebranectomy hit a patient's retina with the laser beam and caused a retinal artery haemorrhage. He also stated that the patient was moving around, and during one of those moves the laser was inadvertently directed to the retina, causing the retinal haemorrhage. The patient visual acuity was reduced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806902-2020-00002 |
| MDR Report Key | 9827918 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-21 |
| Report Date | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS RASHMI PILLAY |
| Manufacturer Street | 3-4 SECOND AVENUE |
| Manufacturer City | MAWSON LAKES, SOUTH AUSTRALIA 5095 |
| Manufacturer Country | AS |
| Manufacturer Postal | 5095 |
| Manufacturer G1 | ELLEX MEDICAL PTY LTD |
| Manufacturer Street | 3-4 SECOND AVENUE |
| Manufacturer City | MAWSON LAKES, 5095 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 5095 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANGO R |
| Generic Name | OPHTHALMIC LASER |
| Product Code | HQF |
| Date Received | 2020-03-13 |
| Model Number | LT5106-T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELLEX MEDICAL PTY LTD |
| Manufacturer Address | 3-4 SECOND AVENUE MAWSON LAKES, 5095 AS 5095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |