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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 380652-37
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)
Event Date 12/08/2021
Event Type  Injury  
Event Description
It was reported that during a da vinci-assisted total hysterectomy, while the surgeon was performing tissue dissection adjacent to the kidney, the renal artery was accidentally damaged with an unspecified da vinci instrument. As a result, the procedure was converted to laparoscopic surgery. A urologist was called in, and the surgeon removed the ipsilateral kidney with the damaged renal artery laparoscopically. The following were confirmed: there was no unintentional robotic arm movement, no collision of instruments, and the patient is reported to be recovering well. The description of the injury on the renal artery was that it was ¿transected. ¿ no malfunction of any da vinci instruments was observed when the vessel injury occurred. The following are unknown: the cause of the reported issue, what da vinci instrument was in use when the vessel injury occurred, the estimated blood loss, if any blood transfusion was rendered to the patient, the details of the vessel repair, and the sequence of events that led to the unplanned nephrectomy.
 
Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication is unknown. Intuitive surgical, inc. (isi) has requested if the da vinci instrument used when the vessel injury occurred will be returned for failure analysis investigation; however, the site stated that there was no allegation that a malfunction of the isi instrument occurred; hence, none of the instruments will be returned to isi for evaluation. If additional information is received, a follow-up mdr will be submitted. No image or video clip for the reported event was submitted for review. A review of the site's complaint history does not reveal any additional complaints related to this event. A review of the site's system logs for the reported procedure date was completed. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: vessel sealer instrument, which is a single-use instrument, and site reviews have shown that no complaints were filed against the instrument. This complaint is considered a reportable event due to the following conclusion: during a da vinci-assisted surgical procedure, the renal artery was accidentally injured by the surgeon. As a result, the kidney was removed. Although the site has confirmed no malfunction of a da vinci instrument was observed during the event; a da vinci instrument was in use when the renal artery was injured, resulting in an unplanned nephrectomy. The cause of the renal artery injury is unknown.
 
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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 Key13227795
MDR Text Key288905455
Report Number2955842-2022-10034
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 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-37
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2016
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: 01/11/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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