MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-16 for LUXOR OPHTHALMIC MICROSCOPES E-71 8065752239 manufactured by Endure Medical, Inc..
[105773619]
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
[105773620]
A customer reported observing a loose caster on the microscope before surgery.
Patient Sequence No: 1, Text Type: D, B5
[118616920]
The system was examined and the reported event was confirmed. The caster was tightened to resolve the issue. The system was tested and found to meet product specifications. The microscope was manufactured on october 21, 2014. Based on qa assessment, the product met specifications at the time of release. The facility is a mobile surgical equipment service, and per information provided, the microscopes are moved frequently as it is transported between customer sites. Therefore, the root cause of the caster coming loose is likely attributed to customer transport/handling. However, with the information provided, this is unable to be determined conclusively. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2018-00764 |
| MDR Report Key | 7433684 |
| Date Received | 2018-04-16 |
| Date of Report | 2018-08-27 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2014-10-21 |
| Date Added to Maude | 2018-04-16 |
| 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 | 2018-04-16 |
| Model Number | E-71 |
| Catalog Number | 8065752239 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-16 |