MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI ROBOT; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bruise/Contusion (1754); Erythema (1840); Hematoma (1884); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Pain (1994); Swelling (2091); Deformity/ Disfigurement (2360); Disability (2371)

Event Date 08/07/2017

Event Type  Injury  

Event Description

I originally had an appointment with dr.(b)(6) on (b)(6) to schedule a hysterectomy for possible adenomyosis.I chose him as a provider based on the receptionist stating he had extensive experience performing hysterectomies.He was unable to perform the hysterectomy on the date requested and referred me to dr.(b)(6) since she was available that date.I had a single incision umbilical davinci robotic hysterectomy on (b)(6) 2017.I requested a different type of hysterectomy and was told by dr.(b)(6) that this type would be the best option for me.My abdomen is red, swollen disfigured and painful in the umbilical surgical area since the hysterectomy.The doctor's surgical report does not match my clinical outcome nor does it match the extreme bruising that occurred immediately in recovery and continued to a lesser degree presently.I have included a picture of the immediate bruising and swelling taken in the hospital.The davinci robotic surgery website shows a photo of an actual patient taken after the procedure and the extensive bruising or swelling is not present indicating that something went wrong in my procedure that was not properly and legally documented.I do not have a bruising disorder or bleeding issue that would account for the outcome.I specifically asked dr.(b)(6) if something went wrong since i never had this type of pain, bruising or swelling with any of the other multiple surgeries i had.She denied any complications which clearly doesn¿t explain the extensive pain and bruising.She stated the recovery would be less since there would only be 1 incision.I passed a large hematoma which i have a photo of and can be provided upon request following the procedure also.She performed an operation as a result of the vaginal cuff dehiscence caused by the passing of the hematoma a few weeks after the original surgery and i still continued to bleed following the repair.I suggested the use of estrace cream to her to help heal the cuff since her silver nitrate treatments weren¿t stopping the bleeding.I complained several times of extreme pain with no answers.I have a mass that is palpable at the surgical site which isn¿t showing on scans and every doctor i have seen after dr.(b)(6) continues to ask me what does dr.(b)(6) thinks about it.Her silence has greatly hindered my subsequent care.No other doctor i have seen with my husband or mother present has seen anything like this and because the injury is a result of her surgery i continue to suffer with no answers and no resolution.Dr.(b)(6) lack of certification, experience performing the specific procedure and denial to perform any other type of safer hysterectomy on me has led to daily pain and disability.The lack of medical documentation legally must represent what actually occurred in the surgical room not omitting the truth which seems to be the case as exhibited by my photo's, pain and disfigurement.The lack of truth by her has hindered the ability of other doctors to help resolve the issue that has caused pain in an area of my body that did not hurt prior to that operation.Please help me get the necessary help i need to eliminate this pain by investigating this case.I recently saw dr.(b)(6) and she said i have muscle damage from the surgery.An investigation is necessary to determine if the davinci robot malfunctioned during surgery because dr.(b)(6) won't say what happened.Fda safety report id # (b)(4).

• Brand Name: DAVINCI ROBOT
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 8760173
• MDR Text Key: 150423774
• Report Number: MW5087853
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 45 YR