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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI XI VISION SIDE SYSTEM Back to Search Results
Model Number 381121-38
Device Problem Failure to Deliver Energy (1211)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/30/2021
Event Type  Injury  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the erbe electrosurgical unit involved with this complaint. However, as of the date of this reported, the failure analysis has not yet been completed. Based on the current information provided, the root cause of the customer-reported failure mode cannot be determined or is unknown. A follow-up mdr will be submitted upon the completion of failure analysis and if additional information is obtained. 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. Additionally, all instruments used in the case were used in subsequent procedures. No image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted radical prostatectomy, the erbe generator was not delivering energy, resulting in blood loss. Although the reported blood loss was 30 ml, it is unknown what medical intervention, if any, was administered due to the bleeding. At this time, the root cause of the customer reported failure mode is unknown.
 
Event Description
It was reported that during a da vinci-assisted radical prostatectomy that the erbe generator was not delivering energy resulting in approximately 30 ml of blood loss. The operating room team power cycled the erbe generator which resolved the issue and the surgeon proceeded with the case. The case was completed robotically.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the erbe electrosurgical unit involved with this complaint. However, as of the date of this reported, the failure analysis has not yet been completed. Based on the current information provided, the root cause of the customer-reported failure mode cannot be determined or is unknown. A follow-up mdr will be submitted upon the completion of failure analysis and if additional information is obtained. 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. Additionally, all instruments used in the case were used in subsequent procedures. No image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted radical prostatectomy, the erbe generator was not delivering energy, resulting in blood loss. Although the reported blood loss was 30 ml, it is unknown what medical intervention, if any, was administered due to the bleeding. At this time, the root cause of the customer reported failure mode is unknown.
 
Event Description
It was reported that during a da vinci-assisted radical prostatectomy that the erbe generator was not delivering energy resulting in approximately 30 ml of blood loss. The operating room team power cycled the erbe generator which resolved the issue and the surgeon proceeded with the case. The case was completed robotically.
 
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Brand NameDAVINCI XI
Type of DeviceVISION SIDE SYSTEM
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 Key13099045
MDR Text Key285220110
Report Number2955842-2021-11821
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number381121-38
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2020
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: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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