MAUDE Adverse Event Report: ENDOSCOPE TOOL; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Erythema (1840); Fever (1858); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Pain (1994); Respiratory Distress (2045); Sore Throat (2396)

Event Date 01/21/2019

Event Type  Injury  

Event Description

I was scheduled for an upper gi endoscopy with dilation on (b)(6) 2019.According to the doctor, the test was completed without incident.However, monday night and tuesday, i was suffering from some major pain under my sternum and a sore throat.The symptoms persisted and by wednesday afternoon i had a low grade fever, deep cough, and more throat pain.By the time i woke up thursday morning, i was unable to swallow, eat, drink and now was presenting with a spiked fever and was coughing up fresh blood and junk.I immediately proceeded to urgent care and sent a message to my gi doctor that performed the procedure.When i arrived at urgent care, i presented with a fever of 99.2 (which for me is equivalent to 100.2 as my normal temp is 97.4).A very irritated red throat and clear lungs.The doctor suspected that i had aspirated during the procedure and contracted some sort of bacteria during the procedure.He prescribed clindamycin and hydrocodone/chlorphen cough syrup.I requested through my primary and gi to test for a type of bacteria and both ignored my request.I feel like maybe this happened to more of his patients and want there to be a protocol to prevent these major infections.I have already missed 3 days of work and counting.In addition, i am in the high risk of infection category and i do not understand why he did not take precautions before the procedure.All attempts to get information on events throughout the procedure have been ignored.

• Brand Name: ENDOSCOPE TOOL
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• MDR Report Key: 8301558
• MDR Text Key: 135843821
• Report Number: MW5083678
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Disability
• Patient Age: 42 YR
• Patient Weight: 54