MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-10 for BRAVO FGS-0312 manufactured by Given Imaging Ltd., Yoqneam.
[92601620]
Investigation summary: the investigation is based on rapid ph graph review and on the graph it appears that the ph level drops below 4 ph and then increases to 8 ph. Dhr (device history record): bravo capsule, lot: 30496q, pass. Since there are ph level surges on the graph, it can be concluded that the capsule detached earlier. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92601621]
According to the reporter, customer called to report a bravo capsule early detachment. Per tech, reviewed study submitted via email, tracings indicate the capsule detached shortly after it was placed. A repeat procedure was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05610 |
| MDR Report Key | 7018907 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-10 |
| Date of Report | 2017-11-10 |
| Date of Event | 2016-04-20 |
| Date Mfgr Received | 2017-01-29 |
| Date Added to Maude | 2017-11-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925297 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Generic Name | CAMERA, STILL, SURGICAL |
| Product Code | FTT |
| Date Received | 2017-11-10 |
| Returned To Mfg | 2017-06-23 |
| Model Number | FGS-0312 |
| Catalog Number | FGS-0312 |
| Lot Number | 30496Q |
| Device Expiration Date | 2017-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-10 |