MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-03 for 23GA VITRECTOMY PROBE FROM 23GA TOTAL PLUS PAK 8065751033 manufactured by Alcon.
[1866714]
During a 23 ga vitrectomy to the left eye, the vitrectomy probe was found to be not working properly: not cutting or removing tissue. The probe was replaced with a single wrapped replacement probe, which worked. The procedure continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2059715 |
| MDR Report Key | 2059715 |
| Date Received | 2011-04-03 |
| Date of Report | 2011-04-03 |
| Date of Event | 2011-02-23 |
| Report Date | 2011-04-03 |
| Date Reported to FDA | 2011-04-03 |
| Date Added to Maude | 2011-04-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 23GA VITRECTOMY PROBE FROM 23GA TOTAL PLUS PAK |
| Generic Name | VITRECTOMY PROBE |
| Product Code | MLZ |
| Date Received | 2011-04-03 |
| Returned To Mfg | 2011-03-01 |
| Model Number | NA |
| Catalog Number | 8065751033 |
| Lot Number | 10031538X |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 0 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-03 |