MAUDE Adverse Event Report: COVIDIEN ENDOCLIP AUTOSUTURE

Model Number 176625

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Septic Shock (2068); Tachycardia (2095); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 11/19/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, i checked into (b)(6) for a simple gall bladder procedure.It was anything but simple.The clamp put on the biliary duct failed, dumping raw bile into my belly.I was in the most extreme pain i have ever felt in my life.They were unable to figure out why i was in such pain, so they transferred me by ambulance to (b)(6), where they found the problem.When i arrived at (b)(6), i was tachycardic 140 bpm, i had aki (acute kidney injury), and i was septic.(septic shock is a serious condition that occurs when a body-wide infection leads to dangerously low blood pressure.) i spent 3 days in the intensive care unit while my body stabilized, and a stent was placed to stop the flow of bile.Again, this was the most intense pain i have ever felt.Ever.The stent inserted by (b)(6) was leaking, so another stent was required.After 31 days of missed work running my business, a weight gain of 48 pounds, and medical bills from (b)(6), i was able to return to a semi normal life.I now deal with ptsd, as it was a horribly emotional as well as physical experience.As the surgeon probably has done many of these procedures in his career, i believe the device was defective.The device used was: (b)(4) endoclip autosuture #176625.I found online where the same model, 176625, has a history of misfiring.In one case, 3 different devices were used before there was a satisfactory application of the clip.I contacted (b)(6) and they claim they have investigated my case and found no negligence on the surgeon or hospital's part.Well, something went horribly wrong, almost to the point of death.I have my medical records from (b)(6), the hospital that saved my life, should you need them.I firmly believe this incident needs to be investigated thoroughly so this atrocity does not happen to anyone else.If i were to punch someone in the face and break their nose, they could surely sue me, and probably win.Conversely, a doctor almost kills me and there is no recourse.This seems totally wrong to me.We place our lives in the hands of people we trust, but when something goes awry, you're on your own.

• Brand Name: ENDOCLIP AUTOSUTURE
• Type of Device: ENDOCLIP AUTOSUTURE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5846117
• MDR Text Key: 51266720
• Report Number: MW5063828
• Device Sequence Number: 1
• Product Code: GDO
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 176625
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 86