MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-07 for GE HEALTHCARE 6TC TEE PROBE KN100105 H45551ZD manufactured by Ge Vingmed Ultrasound As.
[22045254]
It was initially reported on (b)(6) 2012, that a patient suffered soft tissue injury behind the palette with some bleeding after the cardiologist experienced difficulty inserting the ge trans-esophageal echocardiography (tee) probe. After several attempts to obtain additional details of the injury, the initial reporter responded on (b)(6) 2012, reporting swelling and spasm of the epiglottis, excessive probe stiffness that required repeated insertion attempts, significant pressure, and substantial use of viscous lidocaine and versed. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610482-2012-00007 |
| MDR Report Key | 2688130 |
| Report Source | 05,06 |
| Date Received | 2012-08-07 |
| Date of Report | 2012-06-26 |
| Date of Event | 2012-06-07 |
| Date Mfgr Received | 2012-06-26 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE VINGMED ULTRASOUND AS |
| Manufacturer City | HORTON |
| Manufacturer Country | NO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE HEALTHCARE 6TC TEE PROBE |
| Generic Name | TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY PROBE |
| Product Code | DXK |
| Date Received | 2012-08-07 |
| Model Number | KN100105 |
| Catalog Number | H45551ZD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE VINGMED ULTRASOUND AS |
| Manufacturer Address | HORTON NO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-07 |