MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-09 for BIO ENTERICS CORP 50FR E5031-10 manufactured by Bioenterics Corp..
[19782736]
A lighted esophageal bougie used intraoperatively. A disposable tip snaps on & off device. When inserting the bougie, the tip disconnected from the bougie, leaving it in the esophagus. Had to remove it with forceps. Evidently this lighted bougie is a new version of the one staff have used for the past 4 years. The original unit doesn't have a detachable tip; it is permanently attached. According to the mfr the original model is being phased out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014741 |
| MDR Report Key | 192022 |
| Date Received | 1998-10-09 |
| Date of Report | 1998-10-09 |
| Date of Event | 1998-07-17 |
| Date Added to Maude | 1998-10-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO ENTERICS CORP |
| Generic Name | ENDOLUMINA II |
| Product Code | FAT |
| Date Received | 1998-10-09 |
| Returned To Mfg | 1998-08-10 |
| Model Number | 50FR |
| Catalog Number | E5031-10 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 186593 |
| Manufacturer | BIOENTERICS CORP. |
| Manufacturer Address | 1035A CINDY LANE CARPINTERIA CA 93013 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-09 |