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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 Nerve Damage (1979); Pain (1994)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. Therefore, no product is expected to be returned. A follow-up mdr will be submitted if additional information is obtained. No images or videos were obtained for this reported event. A review of the system logs for the procedure date of (b)(6) 2021 has been performed and the following was observed: no relevant errors were observed during this procedure. Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: one fenestrated bipolar forceps instrument (serial number: (b)(4)/ 13 uses remaining. ) a site review has shown that both of the endoscopes used during this procedure (serial numbers: (b)(4) and (b)(4)) have complaints created against them and were returned for failure analysis investigations. However, both of these endoscope had complaints created on (b)(6) 2021 and were used in numerous procedures between (b)(6) 2021 and the complaint creation for this event. No other instruments used during this procedure have a complaint made against them at this time. This event is being reported due to the following conclusion: after undergoing a da vinci-assisted nephrectomy procedure, the patient allegedly experienced nerve damage that requires them to walk with a cane. The patient underwent additional treatment and exams as a result of this injury. The cause of the alleged post-operative complication 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 missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. Information is not available. It is unknown if the initial reporter submitted a report to the fda. Are not applicable.
 
Event Description
It was reported by the patient of the procedure that after a da vinci-assisted nephrectomy procedure with removal of a ureter, the patient awoke from surgery with "extreme pain" in their right leg and could not walk. The surgical procedure reportedly lasted 7. 5 hours. The patient reported visiting the emergency room and undergoing neurology exams, nerve conduction tests, mri imaging, a neurosurgeon exam, and physical therapy, and reported having nerve damage. The patient reported that their status is improving but currently requires a cane to walk. Intuitive surgical, inc. (isi) performed multiple follow-up attempts to obtain additional information. However, as of the date of this report, no further details have been received.
 
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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 Key12874673
MDR Text Key285070139
Report Number2955842-2021-11607
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,Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-48
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2020
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: 11/25/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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