MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for DAVINCI XI 380652-32 N/A manufactured by Intuitive Surgical, Inc.
[184982927]
Based on the current information provided, the cause of the patient? S intra-operative complication and subsequent death is unknown. Isi contacted the site to gather additional patient details. However, the site was unwilling to provide information regarding the patient? S medical history. 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 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 with the exception of the following: 4 green stapler 30 reloads (part #48630g-03) which are single use instrument accessories; 3 white stapler 30 reloads (part #48630w-03) which are single use instrument accessories; 2 green stapler 45 reloads (part #48445g-04) which are single use instrument accessories; 2 white stapler 45 reloads (part #48645w-04) which are single use instrument accessories. This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, the surgeon administered 1 pint of blood to the patient. After doing so, the patient experienced a? Reaction? And subsequently expired. Although the robotics coordinator indicated that the patient? S? Reaction? And subsequent death were related to a blood transfusion and were unrelated to the da vinci surgical system, the cause of the intra-operative bleed is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
Patient Sequence No: 1, Text Type: N, H10
[184982928]
It was initially reported that during a da vinci-assisted surgical procedure, the surgeon called for 1 pint of blood. It was alleged that the blood caused an unspecified reaction and as a result, the patient side cart (psc) was undocked from the patient. Chest compressions were administered. However, the patient ultimately expired. On (b)(6) 2019, intuitive surgical, inc. (isi) contacted the isi clinical sales manager (csm) and gathered the following information: during a da vinci-assisted right lower lobectomy, the surgeon called for one unit of blood, at which time, the csm left the room. The surgeon called for one unit of blood which was administered to the patient. Per a conversation between the csm and the site? S robotics? Coordinator, operating room (or) staff undocked the patient and began chest compressions. After 1 hour of chest compressions, the patient was deemed to have expired. The csm indicated that she did not know what caused the need for additional blood. The csm spoke with the or staff and was informed that they believed the expiration to be due to an issue with the blood transfusion. The csm indicated that there was no allegation that an intuitive product caused or contributed to the reported need for blood or patient expiration. On (b)(6) 2019, isi contacted the robotics coordinator and the following additional information regarding the reported event was obtained: the robotics coordinator verified that the "reaction" experienced by the patient and his/her subsequent death was related to a blood transfusion that was administered. In regards to the reported event, the robotics coordinator stated, "it had nothing to do with the robot. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10230 |
| MDR Report Key | 9881254 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-09-09 |
| Date Mfgr Received | 2019-09-09 |
| 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 | 380652-32 |
| 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 |