MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-20 for LUXOR OPHTHALMIC MICROSCOPES E-71 8065752239 manufactured by Endure Medical, Inc..
[130994665]
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
[130994666]
A healthcare professional reported that the a/c power cord had exposed wires and she received a shock from the exposed wiring. The surgeon had her go to the emergency room (er) to be checked out. Additional information was received reporting that while moving the microscope back to its normal location it shut down, the scrub tech checked the plug at the wall and received a shock from an exposed wire on the cable near the plug. The emergency room doctor stated she was free from harm or any medical issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2018-02662 |
| MDR Report Key | 8184158 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-12-20 |
| 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 | 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 | 3 |
| Brand Name | LUXOR OPHTHALMIC MICROSCOPES |
| Generic Name | MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC |
| Product Code | HRM |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2019-02-05 |
| Model Number | E-71 |
| Catalog Number | 8065752239 |
| Lot Number | ASKU |
| 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 | 2018-12-20 |