MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-12 for ANG-080-D10K manufactured by Applied Medical.
[3606072]
Applied medical 2. 3mm disposable angioscope would not display picture during surgical procedure. Replaced with identical scope which worked fine. Reason for use: left fem-pop bypass with insertion of saphenous vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031421 |
| MDR Report Key | 3289327 |
| Date Received | 2013-08-12 |
| Date of Report | 2013-08-09 |
| Date of Event | 2013-08-09 |
| Date Added to Maude | 2013-08-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 2.3MM DISPOSABLE ANGIOSCOPE |
| Product Code | LYK |
| Date Received | 2013-08-12 |
| Model Number | ANG-080-D10K |
| Catalog Number | ANG-080-D10K |
| Lot Number | 1174936 |
| Device Expiration Date | 2015-08-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | RACHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-12 |