MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-25 for DAVINCI XI 380652-37 N/A manufactured by Intuitive Surgical, Inc.
[184930379]
Based on the information provided the cause of the reported death is unknown. If additional information is received a follow-up mdr will be submitted. Isi has made additional attempts to contact the site and gather patient information. However, no new information has been obtained from the site at this time. A review of the system and instrument logs at the site with a procedure date of (b)(6) 2018 has been performed. There were no observed events in the system logs that would suggest a product issue, and the logged events are in line with normal system functionality. All instruments used during the procedure were used in subsequent procedures. Although there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, based on the information available, the complaint is being reported due to the following conclusion: isi was not able to obtain further details regarding the intraoperative complications and whether they were related to the device. This report has been generated in response to fda inspectional observations dated 06- mar- 2020.
Patient Sequence No: 1, Text Type: N, H10
[184930380]
It was reported that during a da vinci-assisted partial nephrectomy procedure, the surgeon allegedly "got too close" to the patient's aorta and "hit" the aorta, and the patient subsequently expired. On 07-mar-2018, intuitive surgical, inc. (isi) contacted the isi clinical sales representative (csr), who was not present during the procedure but obtained the following additional information regarding the reported event from the site? S robotics coordinator, and a physician? S assistant: during the partial nephrectomy procedure, two surgeons were operating and one of the surgeons? Got too close? To the patient? S aorta and? Hit? The aorta. No allegation was made that a malfunction of a da vinci system, instrument, or accessory occurred. The initial reporters informed the csr that the intraoperative complication was caused by surgeon error. The procedure was recorded by the site but a video was unavailable for isi to review the potential cause of the intraoperative complications. The patient reportedly had pre-existing cardiac issues, however, the cause of death is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10224 |
| MDR Report Key | 9880277 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2018-03-05 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-03-05 |
| Device Manufacturer Date | 2016-12-05 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| 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 | DAVINCI XI |
| Generic Name | PATIENT SIDE CART, 4-ARM |
| Product Code | NAY |
| Date Received | 2020-03-25 |
| Model Number | 380652-37 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death | 2020-03-25 |