MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for DAVINCI XI 380652-31 N/A manufactured by Intuitive Surgical, Inc.
[184930496]
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, isi was unable to obtain additional patient information. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure. Since the product was not available for evaluation and no additional information (lot, serial number, etc. ) could be obtained for the trocar, no further evaluation could be made for the device. A review for system logs at the site was performed and no logs are available for the event since the system was never used. The ifu for the da vinci xi systems (pn - 553873-02) contains the following cautions to minimize the risks associated with port placement: appropriate patient positioning to shift organs away from the port placement site. An adequate level of insufflation. Obturator tip is pointing away from major vessels, organs, and other anatomic structures. When possible, visualization of the entire insertion of the cannula using the endoscope is preferred. Utilize continuous, controlled pressure with a deliberate rotating motion when placing the cannula and obturator. Although there was no allegation of a malfunction of the intuitive trocar that was associated with this event, this event is being reported based on the following conclusion: the surgeon was performing an initial entry without direct visualization and the aorta was injured. The injury to the aorta ultimately resulted in the patient? S death. Additionally, the product was not available for further evaluation to confirm if the device had contributed to the event. This report has been generated in response to fda inspectional observations dated 06-mar-2020.
Patient Sequence No: 1, Text Type: N, H10
[184930497]
It was initially reported that during the da vinci-assisted surgical procedure, an unspecified artery was nicked by the surgeon with an unspecified trocar. The patient reportedly expired. On 17-may-2018, intuitive surgical, inc. (isi) contacted the isi clinical sales representative (csr) who obtained the following additional information from the surgeon/site regarding the reported event: it is not believed that the da vinci surgical system caused/contributed to the patient's operative complication and subsequent death. An intuitive trocar was involved with the aorta injury; however, there was no allegation that a malfunction of the da vinci surgical system, instrument or accessory occurred. It was also reported that the trocar was not inserted with direct visualization. Though there was an autopsy conducted, the results will not be made available to isi.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10225 |
| MDR Report Key | 9880286 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2015-12-04 |
| 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 |
| 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 | 380652-31 |
| 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 |