MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-09 for SAPPHIRE 150TH 54-21204-LF manufactured by Varian X-ray Tube Products.
[33860]
"during surgical procedures, oil started dripping from tube arm assembly. The oil dripped onto the pt causing burns on the abdomin and thigh. "procedure being performed: biopsy, rt flexible ureteroscopy, and possible insertion of double-j stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418956-1997-00001 |
| MDR Report Key | 61878 |
| Date Received | 1997-01-09 |
| Date of Report | 1997-01-09 |
| Date of Event | 1997-01-08 |
| Device Manufacturer Date | 1995-11-01 |
| Date Added to Maude | 1997-01-15 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | SAPPHIRE 150TH |
| Generic Name | ROTATING MEDICAL X-RAY TUBE |
| Product Code | ITY |
| Date Received | 1997-01-09 |
| Model Number | 54-21204-LF |
| Catalog Number | 54-21204-LF |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 62218 |
| Manufacturer | VARIAN X-RAY TUBE PRODUCTS |
| Manufacturer Address | 600 W UNIVERSITY DR ARLINGTON HEIGHTS IL 60004 US |
| Baseline Brand Name | SAPPHIRE 150TH |
| Baseline Generic Name | ROTATING MEDICAL X-RAY TUBE |
| Baseline Model No | 54-21204-LF |
| Baseline Catalog No | 54-21204-LF |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-09 |