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.
[92601217]
The investigation is based on accuview graph review, following review of study it appears that the ph level is above 8ph. Dhr (device history record): bravo capsule, lot: 29781qq, pass. The conclusion is high ph reading due to suspected capsule failure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92601218]
According to the reporter, customer called in to report they have a bravo study which the ph level was very high. Technical support was able to transfer study over for review and it appears that the ph level on this study stayed close to 9 throughout most of the study. A repeat procedure was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05613 |
| MDR Report Key | 7019600 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-10 |
| Date of Report | 2017-11-10 |
| Date of Event | 2016-03-24 |
| 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 | 29781Q |
| Device Expiration Date | 2016-11-01 |
| 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 |