MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1996-11-21 for VITAL VUE PROBE B281-06 manufactured by Sherwood Davis And Geck.
[22077243]
The probe was used in a major operation. Halfway through the operation the probe fractured and light output dropped dramatically. No pt implication was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1996-00010 |
| MDR Report Key | 51282 |
| Report Source | 01,05,06 |
| Date Received | 1996-11-21 |
| Date of Report | 1996-10-22 |
| Report Date | 1996-10-22 |
| Date Reported to Mfgr | 1996-10-22 |
| Date Mfgr Received | 1996-10-22 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 1996-11-27 |
| 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 | 0 |
| 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 | VITAL VUE PROBE |
| Generic Name | IRRIGATION, SUCTION DEVICE-FIBEROPTIC LIGHT SOURCE |
| Product Code | HBI |
| Date Received | 1996-11-21 |
| Model Number | NA |
| Catalog Number | B281-06 |
| Lot Number | 401612 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 51957 |
| Manufacturer | SHERWOOD DAVIS AND GECK |
| Manufacturer Address | BLVD INSURGENTES PARCELA #37 LA MESA TIJUANA BC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-21 |