MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS GE TEE SCOPE PROBE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 6VT-D/ 6VTD

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

After procedure the tee probe was found to have a split in the housing with wires showing by staff as she was person cleaning the scope.Split was not evident prior to the start of the procedure biomed was called and will be coming to pick up the damaged probe for repair.When this was brought to attention, was found this has been occurring will include the info from previous event with same product noticed with cleaning.Fda safety report id # (b)(4).

• Brand Name: GE TEE SCOPE PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS
• MDR Report Key: 15015972
• MDR Text Key: 296009345
• Report Number: MW5110850
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6VT-D/ 6VTD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White