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 2020-01-30 for TANGO LT5106-T manufactured by Ellex Medical Pty Ltd.
[183516939]
The system was quarantined by the user facility only on 30th december and the event reported to ellex on 3rd january. As confirmed by the service engineer for ellex (b)(4), there were no reported complaints /adverse events during this period before the system was quarantined and the event occurrence and also before the event occurred. The device verification (paf) was done on 16th jan 2020 and the system worked to specification. It's not clear whether the injury was serious, as there was no feedback on where (part of the eye) the injury occurred and also no details on whether a medical intervention was required, the patient status nor the device settings used. As no information was forthcoming and the device worked well within specification and the initial complaint reference mentioned [? ] the user not using the system correctly. The only probable cause as advised by the clinician, could be the user choosing the wrong mode (slt instead of yag) which could have led to this event. An evaluation of the labeling / device "usuability" was done and it was deemed adequate.
Patient Sequence No: 1, Text Type: N, H10
[183516940]
Patient underwent capsulotomy at 0. 9mj and experienced ocular hemorrhage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806902-2020-00001 |
| MDR Report Key | 9645558 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Generic Name | OPHTHALMIC LASER |
| Product Code | HQF |
| Date Received | 2020-01-30 |
| Model Number | LT5106-T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2020-01-30 |