MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-09-30 for INTUITIVE manufactured by Intuitive Surgical.
[2740164]
While attempting to remove instrument i was unable to withdraw it completely through the port cannula. The port cannula instrument were visualized using the camera and it was noted that the scissor end had separated from the shaft of instrument. It appeared to have gotten caught on the cannula (port) and broken at that point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2602390 |
| MDR Report Key | 2602390 |
| Report Source | 99 |
| Date Received | 2009-09-30 |
| Date Facility Aware | 2009-08-10 |
| Report Date | 2009-08-24 |
| Date Added to Maude | 2012-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTUITIVE |
| Generic Name | METZ SCISSOR INSTRUMENT |
| Product Code | JOK |
| Date Received | 2009-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-30 |