MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for VESSEL SEALER EXTEND 480422 manufactured by Intuitive Surgical Inc.
[185483180]
Vessel sealer extend instrument was inserted into robotic arm and message appeared that stated "blade is exposed" and advised to take out instrument and inspect the blade and reinsert. Instruction was followed and the same message appeared the second time as well. The instrument was removed and new vessel sealer extend was inserted successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093949 |
| MDR Report Key | 9888514 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VESSEL SEALER EXTEND |
| Generic Name | SYSTEM, SURGICAL, COMPUTR CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2020-03-26 |
| Model Number | 480422 |
| Lot Number | M91191016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL INC |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |