MAUDE Adverse Event Report: UNKNOWN CLIP; CLIP, IMPLANTABLE

Device Problem Defective Device (2588)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 10/24/2022

Event Type  Injury  

Event Description

I had a colonoscopy on (b)(6) 2022 and a clip was placed over a artery that was cut due to removing a large adenoma.For whatever reason the clip failed and 2 days later i was in the icu on with a gi bleed from that exact artery.I was on vasopressors with 5 units of blood needing to be infused.Hospital was able to stop the bleed and i was discharged on (b)(6).However that clip was defective in what it was supposed to do and i almost lost my life because of it.

• Brand Name: CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16254186
• MDR Text Key: 308438255
• Report Number: MW5114539
• Device Sequence Number: 1
• Product Code: FZP
• 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
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: SINGULAIR PRILOSEC.
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White