MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for ULTRAVIT VITRECTOMY PROBE 8065751700 manufactured by Alcon Laboratories, Inc..
[117439736]
Staff reported that a constellation 27+ ultravit handpiece was not working properly. The surgeon noted that the handpiece was suctioning without the footpedal being depressed. A new handpiece was used to complete the procedure as planned and no harm came to the patient. The handpiece was saved for clinical engineering and will be returned to the manufacturer for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7792625 |
| MDR Report Key | 7792625 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-06 |
| Report Date | 2018-08-15 |
| Date Reported to FDA | 2018-08-15 |
| Date Reported to Mfgr | 2018-08-17 |
| Date Added to Maude | 2018-08-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAVIT VITRECTOMY PROBE |
| Generic Name | PROBE, VITRECTOMY |
| Product Code | MLZ |
| Date Received | 2018-08-17 |
| Model Number | 8065751700 |
| Catalog Number | 8065751700 |
| Lot Number | 1949889H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |