FDA Adverse Event Injury Summary report: N

DA VINCI ROBOT

MDR report key: 3851220 · Received May 30, 2014

Report

Report Number
MW5036434
Event Type
Injury
Date Received
May 30, 2014
Date of Event
November 26, 2013
Report Date
May 19, 2014
Product Code
NAY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD A SINGLE-SITE DA VINCI ROBOT GALLBLADDER SURGERY. RECOVERY IMMEDIATELY FOLLOWING SURGERY WAS VERY DIFFICULT, WITHIN 5 DAYS I WAS IN THE ER WITH EXCRUCIATING PAIN IN RIGHT RIB AREA. I WAS HAVING DIFFICULTY CATCHING MY BREATH. THE DOCTOR WAS NOT ABLE TO FIND A PROBLEM, EVEN THOUGH HE DID LAB TESTS, CT SCAN AND X-RAY. SENT ME HOME WITH STRONG PAIN MEDICATION. I DID NOT TAKE ANY MORE PRESCRIPTION PAIN MEDICATIONS FROM THAT DATE ON (B)(6) 2013. I WENT TO THE SURGEON NUMEROUS TIMES WITH THE SAME COMPLAINT OF SERIOUS PAIN IN INCISION SITE AND RIGHT RIB AREA. AFTER ABOUT 8-10 WEEKS HE TOLD ME IT WAS ALL IN MY HEAD AND I COULD GO SEE A NEUROLOGIST IF I WANTED TOO. AT THIS POINT, I DID NOT FEEL THAT IT WAS THE RIGHT PATH, SEEING HOW THERE WAS NOT A DEFINITE DIAGNOSIS. AFTER THE THIRD MONTH OF PAIN, I WENT TO MY PRIMARY CARE DOCTOR (WHO DIAGNOSED THE GALL STONES AND RECOMMENDED THE SURGERY) AND NOTED THAT I DID NOT HAVE THESE ISSUES BEFORE SURGERY. HE ORDERED TWO MORE TESTS, WHICH CAME BACK NEGATIVE. I FOUND INFO ONLINE ABOUT INTERCOSTAL NERVE DAMAGE AND SPOKE WITH MY PRIMARY CARE DOCTOR. HE SUGGESTED THAT I FOLLOW THAT AND FIND A DOCTOR WHO CAN GIVE ME A THORACIC NERVE BLOCK. I HAD THE NERVE BLOCK DONE ON (B)(6) 2014. THAT DID NOT HELP, AND IT CAUSED THE ORIGINAL PAIN TO FLARE UP EVEN MORE. I HAD THE DIFFICULTY OF CATCHING MY BREATH AND SIGNIFICANT PAIN IN MY RIB. I WAS THEN CALLED BY (B)(6) WITH AN APPOINTMENT. WE HAD TRIED TO GET INTO (B)(6), BUT HAD NOT HEARD FROM THEM. I WENT TO (B)(6) AND SAW A NEUROLOGIST. IN HER OPINION, MY PAIN IS NOT READILY ABLE TO BE DIAGNOSED BECAUSE OF THE LOCATION OF THE NERVES AND THE LACK OF KNOWLEDGE IN THE MEDICAL FIELDS ABOUT THIS TYPE OF NERVE PAIN/DAMAGE. SHE RECOMMENDED CHRONIC PAIN MEDICATION, OF WHICH I WILL NOT TAKE BECAUSE OF THE MANY SIDE AFFECTS. STILL HAVE SERIOUS PAIN AT INCISION SITE AND RIGHT RIB AREA. HAVE BEEN TO THE EMERGENCY ROOM TWICE FOR EXCRUCIATING PAIN AND BOTH WITHOUT A REAL DIAGNOSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
319842 DA VINCI ROBOT DA VINCI ROBOT NAY

Patients

Seq Age Sex Outcome Treatment
1 50 YR Other| R| S PROBIOTICS| EXTRA STRENGTH TYLENOL| IRON