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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Date 11/30/2021
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported injury cannot be determined or is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. If additional information is received, a follow-up mdr will be submitted. A site complaint history review was performed and found that there were no other complaints related to this product. A system log review was performed and revealed there were no related system errors to have occurred during the surgical procedure. Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: maryland bipolar forceps instrument and site reviews have shown that no complaints were filed against the instrument. 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 total hysterectomy with a sacrocolpopexy surgical procedure, the common iliac vein tore. As a result, the procedure was converted to open surgery and a vascular surgeon repaired the iliac vein. The amount of bleeding was about 500 ml. The cause of the reported vessel injury is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. Blank mdr fields: follow-up was attempted, but the patient information in sections a and b 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 total hysterectomy with a sacrocolpopexy surgical procedure, approximately 40 minutes into the procedure, the common iliac vein tore. It is unclear what surgical task was being performed when the intra-operative complication occurred. As a result of the vessel injury, the procedure was converted to open surgery. After the conversion to laparotomy, a vascular surgeon took over to repair the injured vessel. The amount of bleeding was about 500 ml, and the patient was reported to be recovering well. As a result of the injury, the planned surgical procedure was not completed. Intuitive surgical, inc. (isi) contacted the or lead, and the following information was obtained: the or lead confirmed there was no malfunction of an isi instrument or system, and it was unknown if a da vinci instrument had contact with the vessel that was injured. No additional information regarding the reported incident was available.
 
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Brand NameDAVINCI XI
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 Key13101568
MDR Text Key287272540
Report Number2955842-2021-11822
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/01/2021
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 Number380652-48
Device Catalogue Number380652
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2020
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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