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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 380652-33
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Insufficient Information (4580)
Event Date 09/14/2021
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. A review of the system logs for the procedure date on (b)(6) 2021 has been performed by an intuitive surgical, inc. (isi) post market surveillance specialist and the following was observed: no relevant errors were observed during this procedure. Additionally, a site history review shows that none of the instruments used during the procedure have a complaint made against them. No image or video clip for the reported event was submitted for review. A review of the site's complaint history shows no other complaints related to this product. This event is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient reportedly experienced a skin burn at an unspecified location. As a result of the alleged skin burn healing slowly, the patient has been seeing a physician. Details regarding the cause, severity, and location of the alleged skin burn are unknown. Blank mdr fields: follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date for section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Field is blank because it is unknown if the initial reporter submitted a report to the fda. Fields are not applicable.
 
Event Description
It was reported by a surgeon that after a da vinci-assisted rectopexy performed on (b)(6) 2021, the patient had a skin burn adjacent to an unspecified site. The patient has reportedly been seeing the surgeon about the slow healing burn wound. The cause, severity, and location of the alleged skin burn are unknown. It is also unknown what medical intervention, if any, has been rendered due to the alleged skin burn. Intuitive surgical, inc. (isi) has performed multiple follow-up attempts to contact the surgeon to obtain additional information. However, as of the date of this report, no further details have been received.
 
Event Description
It was reported by a surgeon that after a da vinci-assisted rectopexy performed on (b)(6) 2021, the patient had a skin burn adjacent to an unspecified site. The patient has reportedly been seeing the surgeon about the slow healing burn wound. The cause, severity, and location of the alleged skin burn are unknown. It is also unknown what medical intervention, if any, has been rendered due to the alleged skin burn. Intuitive surgical, inc. (isi) has performed multiple follow-up attempts to contact the surgeon to obtain additional information. However, as of the date of this report, no further details have been received.
 
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. A review of the system logs for the procedure date on (b)(6) 2021 has been performed by an intuitive surgical, inc. (isi) post market surveillance specialist and the following was observed: no relevant errors were observed during this procedure. Additionally, a site history review shows that none of the instruments used during the procedure have a complaint made against them. No image or video clip for the reported event was submitted for review. A review of the site's complaint history shows no other complaints related to this product. This event is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient reportedly experienced a skin burn at an unspecified location. As a result of the alleged skin burn healing slowly, the patient has been seeing a physician. Details regarding the cause, severity, and location of the alleged skin burn are unknown. Blank mdr fields: follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable. The expiration date for section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Field is blank because it is unknown if the initial reporter submitted a report to the fda. Fields are not applicable.
 
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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 Key13122566
MDR Text Key285676838
Report Number2955842-2021-11836
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
Report Date 12/07/2021
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 Number380652-33
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2015
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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