MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-23 for BRAVO FGS-0312 manufactured by Given Imaging Ltd., Yoqneam.
[90748614]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[90748615]
According to the reporter, the study failed as the capsule dropped into the patient's stomach, no medical intervention was required to remove the capsule. There was no harm to the patient or user due to the alleged device malfunction. A repeat procedure will be necessary.
Patient Sequence No: 1, Text Type: D, B5
[109808433]
Device investigation: the accuview graph from the study was returned for evaluation. The total time of the study was 36:39 hours as opposed to the recommended study time of 48 or 96 hours. The ph readings were found to be at normal values throughout the study. Because information sent from the customer includes only accuview graph, the conclusion of the investigation cannot be positively determined. Although a root cause could not be determined, when the recording stops in this manner, it can be caused by the following: recorder battery failure; a failure of the recorder to receive capsule signals due to failure of recorder components; capsule failure; capsule detached early investigation conclusion for the failure to attach could not be reliably determined. Because the lot number of the capsule was not provided, a dhr review could not be performed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710107-2017-05575 |
| MDR Report Key | 6968275 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-23 |
| Date of Report | 2018-03-19 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2018-02-18 |
| Device Manufacturer Date | 2016-12-12 |
| Date Added to Maude | 2017-10-23 |
| 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 | ELECTRODE, PH, STOMACH |
| Product Code | FTT |
| Date Received | 2017-10-23 |
| Model Number | FGS-0312 |
| Catalog Number | FGS-0312 |
| Lot Number | 33467Q |
| Device Expiration Date | 2017-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-23 |