MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for BRAVO FGS-0636 manufactured by Given Imaging, Inc..
[183908145]
During upper endoscopic exam the procedural md attempted 3 times using 3 different bravo capsules to attach to patient's esophagus before one finally worked. Per endoscopist procedure note: the lumen of the esophagus was moderately dilated. The bravo capsule with delivery system was introduced through the mouth and advanced into the esophagus, such that the bravo ph capsule was positioned 42 cm from the incisors, which was 6 cm proximal to the ge junction. The bravo ph capsule was then deployed and attached to the esophageal mucosa. The delivery system was then withdrawn. Endoscopy was utilized for probe placement and diagnostic evaluation. 3 attempts with capsule failing to attach in the 1st 2 attempts. 3rd attempt showed capsule confirmed attached to esophageal wall. The stomach was normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847632 |
| MDR Report Key | 9847632 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-09 |
| Report Date | 2020-03-10 |
| Date Reported to FDA | 2020-03-10 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Generic Name | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
| Product Code | NEZ |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2019-12-13 |
| Model Number | FGS-0636 |
| Catalog Number | FGS-0636 |
| Lot Number | 47361F |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |