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

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

Patient Problems Failure to Anastomose (1028); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Sepsis (2067); No Code Available (3191)

Event Date 11/03/2017

Event Type  Injury  

Event Description

Husband went in for a prostatectomy at (b)(6) and anticipated one night stay in hospital.Surgeons used the davinci robot and his lower bowel was ct per the pathology report, calling it an enterotomy.It went undetected for 6 days and he needed emergency surgery to remove the infected colon, a temporary colostomy and went septic.He was in the hospital for 28 days and spent 6 days in icu fighting the sepsis and other major issues; needed oxygen for the entire stay, kidneys started to fail.It goes on and on.My husband was immense pain for several days following surgery.Multiple ct (without contrast) and other tests were done.It was not until one of my husbands incisions burst open, leaking bile did we know it was something serious.Even then, it took the surgeon almost 10 hours to even look at my husband and take him to surgery.He's had a total of 3 additional surgeries after the prostatectomy; clean up bile, colostomy, colostomy take down, hernia surgery.These are all directly tied to the prostatectomy surgery.There is much more to our story and thousands of medical records.We have medical records if you need them.There were lots of test done in (b)(6) 2017.Colostomy surgery.Fda safety report id # (b)(4).

• Brand Name: DAVINCI
• Type of Device: SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8659408
• MDR Text Key: 147027273
• Report Number: MW5087070
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 109