MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-06-30 for SCOPO 76 4512-129-06371 NA manufactured by Philips Medical Systems.
[322519]
The side cover strip for the scopo, spot-film device, at the head end of the table had broken. The attending doctor reached down to move it out of the way when the doctor was cut on the finger which needed three stitches. Cover was replaced with no further injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2003-00011 |
| MDR Report Key | 469997 |
| Report Source | 05 |
| Date Received | 2003-06-30 |
| Date of Report | 2003-06-02 |
| Date of Event | 2003-06-02 |
| Report Date | 2003-06-02 |
| Date Reported to FDA | 2003-06-30 |
| Date Mfgr Received | 2003-06-02 |
| Device Manufacturer Date | 1993-02-01 |
| Date Added to Maude | 2003-07-09 |
| 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 |
| Manufacturer Contact | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 2000 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOPO 76 |
| Generic Name | SPOT FILM DEVICE |
| Product Code | IXL |
| Date Received | 2003-06-30 |
| Model Number | 4512-129-06371 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 458843 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | SCOPO 76 |
| Baseline Generic Name | SPOT FILM DEVICE |
| Baseline Model No | 4512-129-06371 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K924593 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-30 |