MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-21 for DAVINCI INTUITIVE SURGICAL SYSTEMS 420484 manufactured by Davinci Surgical.
[2500928]
While performing a robotic lung biopsy by dr (b)(6). The cautery spatula had a piece of it come off at the tip closest to the end. Many attempts to retrieve it were made (approx 20 minutes) and all attempts failed. Surgeon felt it was more potential for harm by continuing to retrieve than to leave it retained. Surgery continued as scheduled and was completed without any further events. Please note this occurred on the 4th use out of 10 possible uses of this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023591 |
| MDR Report Key | 2390198 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-12-21 |
| Date of Event | 2011-12-13 |
| Date Added to Maude | 2011-12-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DAVINCI INTUITIVE SURGICAL SYSTEMS |
| Generic Name | ROBOTIC CAUTERY SPATULA |
| Product Code | GAF |
| Date Received | 2011-12-21 |
| Returned To Mfg | 2011-12-16 |
| Model Number | 420484 |
| Catalog Number | 420484 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVINCI SURGICAL |
| Manufacturer Address | 1266 KIFER RD, BLDG 101 SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-21 |