MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-28 for ENDOWRIST;DAVINCI SI 420184-13 420184 manufactured by Intuitive Surgical, Inc.
[185456929]
Intuitive surgical, inc. (isi) received the permanent cautery spatula instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed/replicated the reported issue and found that the conductor wire? S insulation was damaged, which resulted in thermal damage to the monopolar yaw pulley. Based on the information provided at this time, this complaint is being reported because damage to the conductor wire within the instrument could lead to unintended electrical discharge at a location proximal to the intended location. While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Follow-up was attempted, but the patient information was either unknown or unavailable. The device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system. This reported issue occurred on the instrument's fifth usage and, therefore, had not expired.
Patient Sequence No: 1, Text Type: N, H10
[185456930]
It was reported that during a da vinci-assisted mitral valve repair surgical procedure, a permanent cautery spatula instrument had intermittent issues with cautery. The procedure was completed with no report of patient harm, injury, or adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10240 |
| MDR Report Key | 9894014 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-28 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-04-02 |
| Date Added to Maude | 2020-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID WANG |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4085232100 |
| Manufacturer G1 | INTUITIVE SURGICAL, INC |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOWRIST;DAVINCI SI |
| Generic Name | PERMANENT CAUTERY SPATULA |
| Product Code | NAY |
| Date Received | 2020-03-28 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 420184-13 |
| Catalog Number | 420184 |
| Lot Number | N10190404 668 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Manufacturer Address | 3410 CENTRAL EXPRESSWAY SANTA CLARA CA 95051 US 95051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |