MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for SUREFORM 480460 manufactured by Intuitive Surgical, Inc..
[185505653]
During a robotic sleeve gastrectomy, egd, the davinci sureform 60 stapler stopped working (stapling) for the surgeon. The surgery was halted long enough to replace the device with a new one. There was no harm to the patient and the surgery was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897178 |
| MDR Report Key | 9897178 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-16 |
| Report Date | 2020-03-24 |
| Date Reported to FDA | 2020-03-24 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUREFORM |
| Generic Name | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2020-03-30 |
| Model Number | 480460 |
| Lot Number | L9019119 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC. |
| Manufacturer Address | 1266 KIFER ROAD SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |