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 SI 380614-11 N/A manufactured by Intuitive Surgical, Inc.
[184982459]
Based on the current information provided, the cause of the patient? S intra-operative complication and subsequent death are unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure. Isi has made multiple attempts to contact the site to obtain additional information regarding the reported event. However, the site was unwilling to provide any further details regarding the event. If additional information is obtained, 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 logged events 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 surgical procedure, the patient experienced hemorrhaging from ligated vessels which resulted in a conversion to open surgery. The patient ultimately expired after being transferred to the icu the same day. Although an assistant physician from the site indicated that he/she thinks it was a? Technical issue? And not an event caused by the da vinci surgical system, the cause of the patient? S intra-operative complication and subsequent demise is unknown.
Patient Sequence No: 1, Text Type: N, H10
[184982460]
It was reported that during a da vinci-assisted surgical procedure, the patient experienced hemorrhaging from ligated blood vessels. As a result, the surgical procedure was converted to a thoracotomy and a "heart-lung machine" was attached. The initial reporter indicated that he was present during the first half of the surgery and there were no particular problems with the ligature performed with the da vinci surgical system. According to the initial reporter, the da vinci surgical system was operating normally. However, per the initial reporter, the patient's condition suddenly changed after extubation of the left upper lobe operation. An assistant physician commented that it was caused by massive bleeding from the point where the pulmonary artery (pa) or pulmonary vein (pv) was ligated. A thoracotomy was performed but the patient was still in severe condition and was in the icu with an artificial heart-lung machine. The assistant physician further commented that he/she thinks it was a? Technical issue? And not an event caused by the da vinci surgical system. On (b)(6) 2019, intuitive surgical, inc. (isi) received information confirming that the patient had expired right after the patient had been moved to the icu on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10228 |
| MDR Report Key | 9881047 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2013-09-06 |
| 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 SI |
| Generic Name | PATIENT SIDE CART, 4-ARM |
| Product Code | NAY |
| Date Received | 2020-03-25 |
| Model Number | 380614-11 |
| 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. Required No Informationntervention | 2020-03-25 |