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 2010-08-23 for N/A 8065790022 manufactured by Ascent.
[1348162]
It was reported that during the procedure the tip of the phaco broke off. The tip was retrieved and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8773572]
The phaco tip was visually inspected and found to have broken across the abs port of the phaco tip. The most probable cause of the device failure is due to fatigue. The fatigue is most likely from the ultrasonic energy and caused a crack to form. Due to low sales volume, ascent stopped reprocessing this type of phaco tip in (b)(4) of 2009. This device was reprocessed before ascent stopped the reprocessing of this model.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2010-00008 |
| MDR Report Key | 1811742 |
| Report Source | 05,06,07 |
| Date Received | 2010-08-23 |
| Date of Report | 2010-08-23 |
| Date of Event | 2010-07-22 |
| Date Mfgr Received | 2010-07-26 |
| Device Manufacturer Date | 2009-12-28 |
| Date Added to Maude | 2011-04-08 |
| 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 | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT |
| Manufacturer Street | 10232 SOUTH 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NKX |
| Product Code | NKX |
| Date Received | 2010-08-23 |
| Returned To Mfg | 2010-08-04 |
| Model Number | 8065790022 |
| Catalog Number | 8065790022 |
| Lot Number | 535017SH |
| Device Expiration Date | 2011-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT |
| Manufacturer Address | 10232 S. 51ST STREET PHOENIX FL 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-23 |