MAUDE Adverse Event Report: ROBOTIC ; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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

Patient Problems Abdominal Pain (1685); Flatus (1865); Inflammation (1932); Pain (1994); Pleural Effusion (2010); Pneumothorax (2012); Sepsis (2067); Vomiting (2144); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 06/28/2018

Event Type  Injury  

Event Description

Daughter's letter: it seems like looking back, problems arose after her outpatient office visit with (b)(6) at (b)(6) medical center, when she was consented for the procedure.She had initially been consented for a laparoscopic hysterectomy procedure with robotic as backup and if unsuccessful, they would do an open abdominal incision.She was told if they found adhesions, they would request gi surgery to come in to assist, as they would be on standby and available.On mom requesting my dad be in the room during consent, she apparently denied that and was told by the physician after asking if he should sign as a witness and, (b)(6) had stated that wasn't necessary and she would sign it.After i heard about the robotic procedure, i advised mom to ask about only a laparoscopic surgery without robotic assistance and then open if needed.She called the office the following day and spoke with the secretary and with (b)(6) to saying that she did not want a robotic procedure.The morning of surgery ((b)(6)), her exact procedure was not disclosed and under that stress, we had assumed she would respect my mother's wishes, especially since mom had said this multiple times during her gynecology office visit on (b)(6) 2018 with dr (b)(6).When they tried to give her celebrex, we told them (nurse and resident) she had an allergic to nsaids, which was also listed as an allergy in the computer system, and that she should avoid nsaids.When (b)(6) came out after the procedure to update us.It was quick and she actually did not disclose that she used robotic assistance and only said everything was finished laparoscopically and they didn't need to open her up.She said she did find one adhesion at the site of a previous appendectomy and took it down (did not consent gi as promised to correct the adhesion) but didn't find other adhesions.(b)(6) came to talk to my mom and had told her that she took down an adhesion and also mentioned to her that she even looked at her spleen and liver and everything looked good.In addition, while we were gone, she had been given two doses of toradol post-op for pain control as ordered, despite us specifically stating not to give nsaids and it being listed as an allergy (medication error), pod#1 she did not have nausea but developed worsened bloating and abdominal pain, with minimal gas.They asked her to walk, and she did with help, (b)(6) 2018.Obgyn team persistent on sending me home despite my repeated complaints of severe abdominal pain, vomiting; (b)(6): (b)(6) stated that it was pain, gas pain and i should ambulate.(b)(6), taken to operating room by the gi surgery team to resect the small bowel perforation, (ileal resection and anatomosis performed by gi team.(b)(6), post-operative ct scan revealed several scattered rim enhancing fluid in peritoneal cavity, suspicious for peritonitis and abscess formation, small to no bowel obstruction, diffuse colonic wall thickening.Small to moderate bilateral pleural effusions increased from prior ct results with subtotal collapse of lower lobes, improvement in bladder wall thickening.(b)(6): diagnostic ultrasound guided paracentesis of 150 ml of ascites fluid.(b)(6) x-ray chest and picc line positioning confirmed with x-ray.(b)(6): transferred to (b)(6) icu, and received by emergency surgery team at (b)(6) with picc line for tpn, and nasogastric tube.(b)(6): repeat ct collectors between liver, spleen and along right abdominal wall had increased in size.(b)(6) 2018: discharged home with dht and picc line for at home care through hosp advised in home pt and ot post discharge, (b)(6) home care services for one month, as of now with severe backpain, poor quality of life, insomnia due to ptsd.Sepsis.Identified numerous loculated rim-enhancing fluid collections throughout the abdomen, most conspicuous in the perisplenic and left paracentral mesentery with dilated common bile duct and showed residual bowel wall inflammation.Increasing wbc counts, increased alkaline phosphatase.Total of 9 ct scans were performed and labs everyday for 52 days of my hospitalization.1 ct guided aspiration of frank pus and 1 us guided aspiration of straw colored fluid unto 150 ml.Fda safety report id# (b)(4).

• Brand Name: ROBOTIC
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• MDR Report Key: 8509518
• MDR Text Key: 142217941
• Report Number: MW5085826
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• 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; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 59