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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI X PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI X PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380620-33
Device Problem Visual Prompts will not Clear (2281)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/03/2021
Event Type  Injury  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The isi fse replaced usm 2 to resolve the reported error. The system was tested and verified as ready for use. The usm has not yet been received for failure analysis to be performed. Although the surgeon indicated that the procedure had a risk of bleeding, the cause of the bleeding is unknown. A system log review was performed by an isi failure analysis engineer and following information was provided: approximately 2 and half hours into the procedure, the system detected sensor errors on axis 3 of usm 2. The arm was not able to recover from the error and had to be disabled. The logs suggest that two mid-procedure restarts were performed with no resolve to the reported errors. The system was available for use as a 3 usm system if the usm was disabled. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the patient experienced intra-operative bleeding. The amount of blood loss was reported to be approximately 1300 milliliters (ml) and required mechanical compression, surgical sutures, and the administration of a blood transfusion totaling more than 400ml to be resolved. The procedure was ultimately converted to an open procedure. The cause of the bleeding is unknown. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable.
 
Event Description
It was reported that during a da vinci-assisted nephrectomy-donor surgical procedure, the system displayed error 23118 for universal surgical manipulator (usm) 2 when bleeding was being addressed. The initial reporter confirmed that the bleeding did not occur due to usage of an intuitive surgical, inc. (isi) product. When asked what the surgeon thought the cause of the bleeding could be, the following was provided: ¿from the beginning, the procedure had a risk of bleeding. ¿ it was indicated that the bleeding was coming from "a large blood vessel" and that 1300ml of blood was lost, which required mechanical compression, surgical sutures, and the administration of a blood transfusion totaling more than 400ml to be resolved. The da vinci-assisted surgery was converted to a traditional laparoscopic approach and eventually an open approach to apply the required mechanical compression and surgical sutures. The customer noted that the medical intervention could have been performed with the da vinci surgical system in the absence of the reported error. The reported intraoperative complication and the medical intervention it required resulted in a surgical delay of approximately 1 hour. There were no post-operative complications and the patient's health status was reported to be "good. " he was discharged home. Prior to contacting an isi technical support engineer (tse) the caller (distributor) indicated that the surgeon already converted the procedure. Post-operative troubleshooting was performed. The isi tse had the caller exercise the arm forward and backward and perform a power cycle with the emergency power off function and a circuit breaker reset with no resolve to the reported error. After the isi tse explained that usm 2 could have been disabled and the operating room team could have proceeded using the system as a 3 usm system, the caller was able to disable usm 2 and verified that the system was available for use with the remaining 3 usms. The following was obtained via follow-up with the initial reporter: the system was visually inspected after power-on and no errors were displayed. The instruments, camera, and accessories were visually checked and no issues were identified. More generally, no issues or abnormalities were identified prior to the reported error¿s occurrence. The following explanation was provided when asked why the site did not contact isi technical support: "the [da vinci-assisted nephrectomy] procedure at its critical point requires clamping of the renal vessels prior to tumor resection. The patient's condition during the procedure and the surgeon's previous activities, e. G. System restart, evacuation of instruments, did not leave much time for contact with isi technical support. ".
 
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Brand NameDAVINCI X
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13119205
MDR Text Key287273093
Report Number2955842-2021-11834
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K171294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380620-33
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2022
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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