MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-29 for DA VINCI SURGICAL 420184 manufactured by Intuitive Surgical.
[18504360]
Sterile processing dept. Found a piece of the protective cautery sheath was missing after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023645 |
| MDR Report Key | 2396771 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-12-13 |
| Date Added to Maude | 2012-01-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Brand Name | DA VINCI SURGICAL |
| Generic Name | PERM CAUTERY SPATULA |
| Product Code | HHT |
| Date Received | 2011-12-29 |
| Model Number | 420184 |
| Lot Number | M10110726 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL |
| Manufacturer Address | 1766 KIFER RD. BLDG. 101 SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-29 |