MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-06-09 for 8065740809 manufactured by Ascent Healthcare Solutions.
[846052]
Before the procedure started, the phaco tip was not oscillating and broke off. The tip fell into patient's eye and was retrieved. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8077815]
The used device has been returned, however, a device analysis has not yet been completed. Upon completion of the investigation, a follow-up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2008-00003 |
| MDR Report Key | 1058784 |
| Report Source | 05,06,07 |
| Date Received | 2008-06-09 |
| Date of Report | 2008-06-09 |
| Date of Event | 2008-05-09 |
| Date Mfgr Received | 2008-05-12 |
| Device Manufacturer Date | 2008-04-23 |
| Date Added to Maude | 2008-08-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 SOUTH 51ST ST. |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Product Code | NKX |
| Date Received | 2008-06-09 |
| Returned To Mfg | 2008-05-16 |
| Catalog Number | 8065740809 |
| ID Number | 815920F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1091218 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | PHOENIX AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-09 |