MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-05 for INNER VISIONS manufactured by Medovations.
[1632675]
Pt having laparoscopic nissen fundoplication - surgeon utilized lighted bougie in esophagus - when bougie removed, the lighted tip had become detached from the tubing and was retained in the pt's throat... Pt with difficulty breathing in recovery room. Bougie was found in pt's throat when she coded and re-intubation was attempted. Bougie removed and pt had immediate relief - pt experienced injury to vocal cords which most likely is not permanent. It is the impression of the surgeons that there is a design defect with this piece of equipment as the bougie will light up even if it is not properly seated on the tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017017 |
| MDR Report Key | 1793588 |
| Date Received | 2010-08-05 |
| Date of Report | 2010-08-05 |
| Date of Event | 2010-05-26 |
| Date Added to Maude | 2010-08-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER VISIONS |
| Generic Name | LIGHTED BOUGIE |
| Product Code | FAT |
| Date Received | 2010-08-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOVATIONS |
| Manufacturer Address | 102 E KEEFE AVE. MILWAUKEE WI 53212 US 53212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2010-08-05 |