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

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.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT 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 Key: 13122566
• MDR Text Key: 285676838
• Report Number: 2955842-2021-11836
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-33
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female