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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Pain (1994); Swelling (2091)
Event Date 04/01/2019
Event Type  Injury  
Event Description
Had severe complications following gall bladder removal using the da vinci surgical robot. Here is a brief summary of events. I can provide more data if needed. On (b)(6) 2019 went to er for severe stomach pain. Diagnoses was gallstones and swollen kidney. Referred to gi doc (b)(6) 2019 went to surgery consult at sentara robotic surgery was scheduled (cholecystectomy) as it was the easiest and least impacting option with the quickest recovery. Doctor said one week recovery time (b)(6) 2019, day of surgery: post surgery had very serious pain that was barely alleviated with narcotic medication. Doctor said the surgery went well with no complications. Pain was still very bad upon getting discharged the same day(b)(6) 2019 two days after surgery took picture of incision and area around it was completely red and purple. Bruising from surgery was still visible a year after surgery still having severe pain and called the sentara office for help. Sugeon suggested take double pain medication to alleviate. 2x percocet pills rather than one every 4 hours. Alleviated pain for 3 hours before pain began to re-surface (b)(6) 20219 my wife had to call hospital/doctor to get more medicine as i was still in severe pain (b)(6) 2019, a week after surgery called doctor again as pain and bruising were still so severe. Doctor said is normal and to keep on pain medicine as needed. I used all percocet pain medication prescribed from original prescription and the refill on (b)(6) 2019, at two-week follow-up with surgeon, he said i was in the 1% where the recovery takes this long. The attending nurse was surprised i used all the pain meds. When the surgeon saw the bruising around my incision, he had a look of shock on his face. This is when i started to get a feeling that this wasn't normal approximately (b)(6) 2019 after 4 weeks made a follow-up with my pcm who was very surprised i was still having pain from the surgery. She order a battery of tests, blood and imaging (ct), as she suspected it was a stone potentially stuck in the bile duck or i had a bile leakage. She also prescribed more percocet for the pain about a week later after the tests were done made another follow-up with the surgeon. After his exam and review of the imaging he said i have a hernia by my naval which is causing the pain. Suggested a second surgery to insert a permanent suture to fix. He seemed uneasy and wanted to schedule the second surgery right away. I was skeptical and made an appt for a second opinion (b)(6) 2019 went to another surgeon for a second opinion. He said it was not hernia and instead suggested my rectus abdominal muscle (abdominal wall) was damaged during surgery with the da vinci robot and is causing the pain. Said i should take pain medication (motrin) religiously for next two weeks and should go away. It didn't (b)(6) 2019 3rd surgeon opinion on (b)(6). Said it is hernia said robotic surgery with the single incision site can cause more bruising than traditional surgery (b)(6) 2019, (b)(6) follow-up with pcm pain still exists in same spot (by incision) still taking narcotics for pain. Believes it's an injury to my abdomen during robotic surgery which caused severe internal bleeding (b)(6) 2019 (b)(6) 4th surgeon opinion surgeon said not likely a hernia did not agree with that this surgery was done robotically. Said it was unnecessary. On (b)(6) 2019 (b)(6) follow-up with 4th surgeon suggested it is abdominal wall injury from robotic surgery 4th quarter 2019 referred to (b)(6) lost 50 pounds by now severe abdominal pain everyday require a cane to walk most of the time (b)(6) 2020 had appointment with (b)(6) surgeon in early (b)(6) 2020. Upon his examination of the surgical area he said he could put his finger farther into my belly than should be possible. In his opinion there was an injury or severe complication from how the first surgery was performed. Scheduled 2nd surgery for (b)(6) 2020 to correct the injury. Fda safety report id # (b)(4).
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MDR Report Key11163524
MDR Text Key227034890
Report NumberMW5098805
Device Sequence Number1
Product Code NAY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/12/2021 Patient Sequence Number: 1