MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for LUXOR OPHTHALMIC MICROSCOPES E-71 8065752239 manufactured by Endure Medical, Inc..
[138906819]
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
[138906820]
A customer reported that the screw on the side that stops the microscope head from going up or down came off before surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2019-00404 |
| MDR Report Key | 8414451 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-07-12 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2012-12-13 |
| Date Added to Maude | 2019-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| 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 | 2019-03-12 |
| Model Number | E-71 |
| Catalog Number | 8065752239 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-12 |