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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 380652-39
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Pain (1994); Cancer (3262)
Event Date 11/02/2017
Event Type  Injury  
Event Description
As part of a legal dispute intuitive surgical, inc. (isi) received information from a legal document regarding a patient that underwent a da vinci procedure. The legal document alleges that on (b)(6) 2017 the surgeon of record used ¿the da vinci robotic surgical system¿ to perform a complete hysterectomy ¿ bilateral salpingo-oophorectomy. The legal document alleges that, ¿due to complications during the procedure, the surgery lasted over 8 hours rather than the projected 4-hour duration. Removal through the vaginal canal presented challenges. The surgeon encountered multiple lesions and adhesions, which obstructed ability to continue with the robotic assisted surgery to perform the complete hysterectomy. Instead of moving to the abdominal removal of the uterus, the surgeon continued with robotic assisted procedure and performed some of the surgery by manually severing lesions and adhesions followed by forcible removal of the uterus through the vaginal canal. ¿ the legal document alleges that the ¿forcible removal of the uterus, fallopian tubes and ovaries resulted in what is apparently lifetime damage to the plaintiff (patient's surname) bladder and urethra. Plaintiff did not discover the lifetime damage until about (b)(6) 2018, when all treatments for relief of urethra/bladder pain failed and the constant, relentless pain that occurs with each urination exists today. ¿ the legal document alleges that the patient experienced postoperative pain and fever resulting in postoperative doctor visits and diagnostic ct scan testing which allegedly ¿revealed an abscess at the vaginal cuff¿. The legal document alleges the surgeon of record attempted to treat the abscess with oral antibiotics and additional hospitalization and that draining of the abscess was considered but not performed due to the location of the abscess. The patient was treated with oral antibiotics while in the hospital. The patient was released. Once released, the pain in patient's bladder and urethra continued. The patient allegedly continued to inquire about the bladder and urethra pain and the surgeon of record ¿represented¿ to the patient that there was ¿a 301b tumor that was removed along with the uterus which proved to be difficult to remove¿. At this point, the surgeon of record ¿prescribed medicine for what was believed to be nerve damage¿ but the ¿medicine did not relieve the pain¿. The patient ¿completed her treatment with the surgeon of record in (b)(6) 2018¿. The legal document alleges that the patient ¿was diagnosed in (b)(6) 2020 with metastatic endometrial cancer with a large tumor at the vaginal cuff that compressed the bladder thereby causing hydronephrosis and underwent chemotherapy for several months and had to undergo surgery for placement of a nephrostomy tube to relieve the hydronephrosis¿. The legal document alleges that the patient ¿was diagnosed in (b)(6) 2021 with recurrent endometrial metastatic cancer. Plaintiff is informed and believes and thereon alleges that the spread of her endometrial cancer that was contained within the uterus is a result of the [surgeon of record¿s] negligent operation of the da vinci robotic surgical system; the inherent dangers and known complications of utilizing the da vinci robotic surgical system¿. It is also alleged that, ¿the cancer that now exists in [patient] is further caused by the negligent operation of the da vinci system by [the surgeon of record] and/or the manufacturing defects that inherent in the da vinci system which [patient] believes caused burns, tears, cuts in surrounding organs thereby releasing cancer cells into areas of the abdomen when the cancer would not be released into those areas otherwise. ¿ per regulatory memo dated (b)(6) 2019, follow-up activities, including investigation that would require contacting the hospital, surgeon, and/or the patient related to the legal complaint will be performed by the legal department and/or outside legal counsel as part of the litigation process. The standard legal case will include grievance against the surgeon, hospital, and other involved parties making it infeasible for the post market surveillance department to gain additional information about the event outside of this legal process.
 
Manufacturer Narrative
Based on the information provided, the root causes of the reported complications cannot be determined. A follow-up mdr will be submitted if additional information is obtained. Site history review: as of 10/28/2021, a review of the site's complaint history does not show any additional complaints related to this product and/or this event. As of 28-oct-2021, a review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. A review of the system and instrument logs has been performed. There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality. Additionally, all reusable instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against the instruments. This complaint is reportable due to the following: the legal document alleges that during a da vinci-assisted procedure, there was a procedure delay, challenges with patient anatomy, and ¿forcible removal of the uterus, fallopian tubes and ovaries" which resulted in what was cited as a "lifetime damage to the patient¿s bladder and urethra¿. It is also alleged that the patient experienced postoperative pain and fever for which doctor visits and diagnostic ct scan testing were performed resulting in an alleged abscess of the vaginal cuff that was treated with oral antibiotics and additional hospitalization. Further, the patient was allegedly prescribed pain medication for alleged nerve damage. The patient suffered a recurrence of endometrial cancer to the cuff of the vagina in 2020 and a recurrence of endometrial cancer in 2021 allegedly due to the surgeon's negligent operation of the da vinci system and ¿the inherent danger and known complications of the da vinci robotic surgical system. ¿ at this time, the root causes of the complications are unknown.
 
Manufacturer Narrative
Based on the information provided, the root causes of the reported complications cannot be determined. A follow-up mdr will be submitted if additional information is obtained. Site history review: as of 10/28/2021, a review of the site's complaint history does not show any additional complaints related to this product and/or this event. As of 28-oct-2021, a review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. A review of the system and instrument logs has been performed. There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality. Additionally, all reusable instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against the instruments. This complaint is reportable due to the following: the legal document alleges that during a da vinci-assisted procedure, there was a procedure delay, challenges with patient anatomy, and ¿forcible removal of the uterus, fallopian tubes and ovaries" which resulted in what was cited as a "lifetime damage to the patient¿s bladder and urethra¿. It is also alleged that the patient experienced postoperative pain and fever for which doctor visits and diagnostic ct scan testing were performed resulting in an alleged abscess of the vaginal cuff that was treated with oral antibiotics and additional hospitalization. Further, the patient was allegedly prescribed pain medication for alleged nerve damage. The patient suffered a recurrence of endometrial cancer to the cuff of the vagina in 2020 and a recurrence of endometrial cancer in 2021 allegedly due to the surgeon's negligent operation of the da vinci system and ¿the inherent danger and known complications of the da vinci robotic surgical system. ¿ at this time, the root causes of the complications are unknown.
 
Event Description
As part of a legal dispute intuitive surgical, inc. (isi) received information from a legal document regarding a patient that underwent a da vinci procedure. The legal document alleges that on (b)(6) 2017 the surgeon of record used ¿the da vinci robotic surgical system¿ to perform a complete hysterectomy ¿ bilateral salpingo-oophorectomy. The legal document alleges that, ¿due to complications during the procedure, the surgery lasted over 8 hours rather than the projected 4-hour duration. Removal through the vaginal canal presented challenges. The surgeon encountered multiple lesions and adhesions, which obstructed ability to continue with the robotic assisted surgery to perform the complete hysterectomy. Instead of moving to the abdominal removal of the uterus, the surgeon continued with robotic assisted procedure and performed some of the surgery by manually severing lesions and adhesions followed by forcible removal of the uterus through the vaginal canal. ¿ the legal document alleges that the ¿forcible removal of the uterus, fallopian tubes and ovaries resulted in what is apparently lifetime damage to the plaintiff (patient's surname) bladder and urethra. Plaintiff did not discover the lifetime damage until about (b)(6) 2018, when all treatments for relief of urethra/bladder pain failed and the constant, relentless pain that occurs with each urination exists today. ¿ the legal document alleges that the patient experienced postoperative pain and fever resulting in postoperative doctor visits and diagnostic ct scan testing which allegedly ¿revealed an abscess at the vaginal cuff¿. The legal document alleges the surgeon of record attempted to treat the abscess with oral antibiotics and additional hospitalization and that draining of the abscess was considered but not performed due to the location of the abscess. The patient was treated with oral antibiotics while in the hospital. The patient was released. Once released, the pain in patient's bladder and urethra continued. The patient allegedly continued to inquire about the bladder and urethra pain and the surgeon of record ¿represented¿ to the patient that there was ¿a 301b tumor that was removed along with the uterus which proved to be difficult to remove¿. At this point, the surgeon of record ¿prescribed medicine for what was believed to be nerve damage¿ but the ¿medicine did not relieve the pain¿. The patient ¿completed her treatment with the surgeon of record in (b)(6) 2018¿. The legal document alleges that the patient ¿was diagnosed in (b)(6) 2020 with metastatic endometrial cancer with a large tumor at the vaginal cuff that compressed the bladder thereby causing hydronephrosis and underwent chemotherapy for several months and had to undergo surgery for placement of a nephrostomy tube to relieve the hydronephrosis¿. The legal document alleges that the patient ¿was diagnosed in (b)(6) 2021 with recurrent endometrial metastatic cancer. Plaintiff is informed and believes and thereon alleges that the spread of her endometrial cancer that was contained within the uterus is a result of the [surgeon of record¿s] negligent operation of the da vinci robotic surgical system; the inherent dangers and known complications of utilizing the da vinci robotic surgical system¿. It is also alleged that, ¿the cancer that now exists in [patient] is further caused by the negligent operation of the da vinci system by [the surgeon of record] and/or the manufacturing defects that inherent in the da vinci system which [patient] believes caused burns, tears, cuts in surrounding organs thereby releasing cancer cells into areas of the abdomen when the cancer would not be released into those areas otherwise. ¿ per regulatory memo dated (b)(6) 2019, follow-up activities, including investigation that would require contacting the hospital, surgeon, and/or the patient related to the legal complaint will be performed by the legal department and/or outside legal counsel as part of the litigation process. The standard legal case will include grievance against the surgeon, hospital, and other involved parties making it infeasible for the post market surveillance department to gain additional information about the event outside of this legal process.
 
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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 Key12858290
MDR Text Key286231255
Report Number2955842-2021-11573
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
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number380652-39
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2017
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: 11/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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