MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for LUXOR OPHTHALMIC MICROSCOPES E-71 8065752304 manufactured by Endure Medical, Inc..
[108991830]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108992031]
A customer reported that the scope head was loose. Event timing and patient impact is not known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2018-01058 |
| MDR Report Key | 7531720 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-08-02 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2014-09-22 |
| Date Added to Maude | 2018-05-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ENDURE MEDICAL, INC. |
| Manufacturer Street | 1455 VENTURA DR |
| Manufacturer City | CUMMING GA 30040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LUXOR OPHTHALMIC MICROSCOPES |
| Generic Name | MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2018-06-29 |
| Model Number | E-71 |
| Catalog Number | 8065752304 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDURE MEDICAL, INC. |
| Manufacturer Address | 1455 VENTURA DR CUMMING GA 30040 US 30040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-22 |