MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 9T-RS; 9T-RS ULTRASOUND TRANSDUCER

Lot Number 31452/6030037WX0

Device Problem Problem with Removal of Enzymatic Cleaner (1213)

Patient Problem Gastroesophageal Burn (4475)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

Block a: patient information could not be obtained due to country privacy laws.Block d4, udi: (b)(4)(probe),(console).Block e1: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: hcs horten - strandpromenaden 45 norway horten vestfold, n-3191, hcs wuxi - no.19 changjiang road national hi-tech dev.Zone china wuxi jiangsu, 214028.Initial information provided indicates the probe had reached the temperature limit and the system stopped transmitting energy as designed, and logfile analysis confirms this.Additionally, the gehc service engineer performed preliminary probe analysis and no probe malfunction was observed.Ge healthcare's investigation as to whether the adverse event is a thermal burn or a chemical burn, and whether or not there is a malfunction is on-going at this time.

Event Description

Gehc received a foreign user facility injury report of a pediatric patient injury post heart valve replacement surgery.The patient was undergoing heart valve surgery where the 9t-rs was being used along with the vivid iq for visualization to assist in the surgery.Afterwards, it was noted that the patient may have had a burned esophagus.Symptoms include black saliva, a brown hemi circle in the anterior esophagus and a brown spot on the lips.

Manufacturer Narrative

Ge healthcareâ s investigation has completed, and it is concluded that the patient burn while using a vivid iq with a 9t-rs probe during cardiac surgery has not occurred due to device malfunction.Gehcâ s investigation of the cause of the patient burn considered multiple hazardous situations: overheating, probe damage allowing disinfectant to get inside, and probe reprocessing.Overheating and probe damage were ruled out through device evaluation.Additionally, it was observed from the visual inspection of the probe that there was significant build-up of biomatter residue which may soak up disinfectant fluids when the probe is not wiped as indicated within the probe reprocessing instructions.Based upon further assessments, it was concluded that the amount of residue observed on the probe would not have occurred if the ge healthcare probe reprocessing instructions regarding wiping of the endoscope during pre-cleaning and after each rinsing step were followed.Lastly, the complaint file was reviewed for similar issues and there is no indication of any systemic issue nor an issue with probe reprocessing instructions.Risk mitigations currently in place are verified to be effective and have reduced the risk as far as possible (afap) within the clinical use scenario.Based upon this investigation it is concluded that no corrective or preventive action is necessary.The customer will be provided gehcâ¿¿s investigation conclusions, and they will be provided with an opportunity to discuss gehcâ¿¿s probe reprocessing techniques in further detail.

• Brand Name: 9T-RS
• Type of Device: 9T-RS ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer (Section G): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: a1060; wauwatosa, WI 53226-4856
• MDR Report Key: 16903760
• MDR Text Key: 314927028
• Report Number: 9610482-2023-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K181727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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 Lot Number: 31452/6030037WX0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 10 YR
• Patient Sex: Male