MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for TIP COVER ACCESSORY FOR USE WITH ENDOWRIST MONOPOLAR SCISSORS 400180 manufactured by Intuitive Surgical, Inc..
[185225489]
During the case it was noted that the tip cover was splitting. If it is not covering the scissors appropriately it can burn the patient, as well as obvious complications if it is lost in the abdomen. The tip cover was changed, and the procedure finished without incident. The defective tip cover was sequestered and intuitive notified. This is the fourth event with a tip cover in two months [only product saved at this time].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888558 |
| MDR Report Key | 9888558 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-06 |
| Report Date | 2020-03-09 |
| Date Reported to FDA | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIP COVER ACCESSORY FOR USE WITH ENDOWRIST MONOPOLAR SCISSORS |
| Generic Name | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2020-03-27 |
| Model Number | 400180 |
| Lot Number | M191191107 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-27 |