MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for DAVINCI XI 380652-22 N/A manufactured by Intuitive Surgical, Inc.
[184982605]
Based on the current information provided, the cause of the patient? S intra-operative complication and subsequent death is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure. Isi has attempted to contact the site to gather additional information regarding the patient. However, as of the date of this report, no new information has been obtained. If additional information is received, a follow-up mdr will be submitted. A review of the system and instrument logs has been performed. There were no observed events in the system logs that would suggest a product issue, and are in line with normal system functionality. The log review supports the customer claim that there was no product issue during the case. Additionally, all instruments used in the case were used in subsequent procedures. This complaint is being reported due to the following conclusion: during a da vinci-assisted thymectomy procedure, the surgeon made the decision to convert to open surgery for an unclear reason. After converting to open surgery, the surgeon indicated that the patient? S aorta ruptured during attempts to split a tumor which was described as being big. Although the surgeon indicated that the patient? S aorta ruptured while using a non-da vinci instrument, the cause of the operative complication is unknown.
Patient Sequence No: 1, Text Type: N, H10
[184982606]
It was initially reported that during the da vinci-assisted thymectomy procedure, the surgeon damaged the patient's aorta intra-operatively with a curved bipolar dissector instrument. The case was converted to open surgery; however, the patient reportedly expired. There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. On (b)(6) 2018, intuitive surgical, inc. (isi) contacted the surgeon and obtained the following additional information regarding the reported event: the surgeon does not believe that the death of the patient is attributed to a da vinci surgical system including the curved bipolar dissector instrument. The surgeon believes the cause of the patient? S death was a rupture of the aorta after controlled conversion to open surgery due to an instrument. No malfunction of the curved bipolar instrument occurred during the surgery. After conversion to open surgery, the surgical staff tried to get to the aorta but the tumor was very big. As a result, they tried to split the tumor in half. During this act they ruptured the aorta with a non da vinci instrument. The bleeding could not be stopped. The procedure was not recorded on video. The cause of death as it appears on the death certificate/autopsy report/discharge summary was? Bleeding due to aorta rupture.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2018-10820 |
| MDR Report Key | 9881416 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2014-11-21 |
| 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 | 380652-22 |
| 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; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-25 |