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U.S. Department of Health and Human Services

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

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ENDOSCOPE TOOL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
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.

 
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Brand NameENDOSCOPE TOOL
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
MDR Report Key8301558
MDR Text Key135843821
Report NumberMW5083678
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received02/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/01/2019 Patient Sequence Number: 1
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