MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D ULTRASOUND TRANSDUCER; DIAGNOSTIC ULTRASOUND TRANSDUCER

Model Number 6VT-D

Device Problem Crack (1135)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

A customer has reported, via a medwatch, that after a tee procedure the staff cleaning the 6vt-d probe found a split within the articulation-end covering and wires were exposed.Additionally, they noted the split was not present prior to the procedure.No patient injury was reported.

Manufacturer Narrative

Udi: (b)(4).Legal manufacturer: (b)(4).Gehc began an investigation of the report and has obtained some additional information from the customer.Engineering has evaluated images provided by the customer along with the incident description provided by the customer and concluded the following.The damage, a large cut and/or split within the deflection/articulation section cover has most likely occurred during extraction of the probe when this section passes over the teeth of the patient as the probe is withdrawn rapidly.The bite guard is typically used up until this point, and most users remove the bite guard just prior to this phase of the exam.Historically we have seen that this phase, extraction, has the most stress on the probe covering.Additionally, it is unlikely that there was a patient bite during intubation, as the fingers of the doctor are also often in the mouth to guide the probe carefully down the upper part of the esophagus past the gag muscle.Lastly, prior to the event the probe was repaired by a third-party, and gehc observed the usage of different material.Therefore, the large cut may be due to the use of deflection/articulation section materials which do not meet ge specifications, as this probe has been repaired by a third-party repair center without access to ge proprietary design information and materials.

• Brand Name: 6VT-D ULTRASOUND TRANSDUCER
• Type of Device: DIAGNOSTIC ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-318 3; NO N-3183
• 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: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 15302826
• MDR Text Key: 303267522
• Report Number: 9610482-2022-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6VT-D
• Device Lot Number: 213015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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